FDA Product Code
FDA Product Code HET — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.1720
510(k) Clearances — 338 records · page 2 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K955412 | A.S.D. SAFETY TROCAR | American Surgical Devices | 1996-05-14 | Traditional | PDF ↗ |
| K954775 | FLO-STAT FLUID MONITORING SYSTEM | Gynecare Innovation Center | 1996-05-10 | Traditional | PDF ↗ |
| K960262 | CORING MORCELLATOR | Cook Urological, Inc. | 1996-04-15 | Traditional | PDF ↗ |
| K951343 | KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES | KARL STORZ Endoscopy-America, Inc. | 1996-04-11 | Traditional | PDF ↗ |
| K955403 | OES LAPARO-THORACO VIDEOSCOPE TYPE V | Olympus America, Inc. | 1996-03-11 | Traditional | PDF ↗ |
| K955456 | OES LAPARO-THORACO VIDEOSCOPE (RIGID) | Olympus America, Inc. | 1996-02-22 | Traditional | PDF ↗ |
| K942389 | TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES | Hogan & Hartson | 1996-02-16 | Traditional | PDF ↗ |
| K953360 | R-MED ABDOMINAL WALL ELEVATOR | R-Med, Inc. | 1996-01-11 | Traditional | PDF ↗ |
| K952889 | INSUL-COAT/2 CERAMIC COATED ENDO MEDICAL INSTRUMENTS | Materials Conversion Corp. | 1995-12-22 | Traditional | PDF ↗ |
| K953364 | SPECULITE | Trylon Corp. | 1995-12-08 | Traditional | PDF ↗ |
| K943305 | OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM | Olympus America, Inc. | 1995-11-17 | Traditional | PDF ↗ |
| K953809 | KARL STORZ TAKE-APART BIOPOLAR FORCEPS | KARL STORZ Endoscopy-America, Inc. | 1995-11-06 | Traditional | PDF ↗ |
| K942838 | OLYMPUS SUPERVIEW LAPAROSCOPE FOR OB/GYN | Olympus America, Inc. | 1995-10-31 | Traditional | PDF ↗ |
| K951105 | KARL STORZ PRESSURE CUFF FOR USE WITH THE KSEA HYDROMAT PUMP | KARL STORZ Endoscopy-America, Inc. | 1995-10-20 | Traditional | PDF ↗ |
| K954520 | MICROSURGE VERESS NEEDLE | Microsurge, Inc. | 1995-10-16 | Traditional | PDF ↗ |
| K942431 | LAPOROSCOPIC SCISSORS | Enterprise Medical Corp. | 1995-10-11 | Traditional | PDF ↗ |
| K953190 | KSEA MODEL 203200 20 UNIMAT | KARL STORZ Endoscopy-America, Inc. | 1995-10-05 | Traditional | PDF ↗ |
| K953574 | NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER | American Hydro-Surgical Instruments, Inc. | 1995-09-29 | Traditional | PDF ↗ |
| K940265 | PATTON LAPAROSCOPIC CATHETER INTRODUCER SET | Cook Urological, Inc. | 1995-09-28 | Traditional | PDF ↗ |
| K953548 | LAPAROSCOPIC SURGICAL INSTRUMENT | Gabris Surgical Corp. | 1995-09-19 | Traditional | PDF ↗ |
| K944200 | HI-Q HAND INSTRUMENTS, OB/GYN USE | Olympus America, Inc. | 1995-09-15 | Traditional | PDF ↗ |
| K951250 | KARL STORZ SUCTION CATHETERS | KARL STORZ Endoscopy-America, Inc. | 1995-09-07 | Traditional | PDF ↗ |
| K952508 | FLOW-THERME, WISAP #7642 | Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh | 1995-08-25 | Traditional | PDF ↗ |
| K943100 | STRYKER OPERATING LAPAROSCOPE | Stryker Endoscopy | 1995-08-10 | Traditional | PDF ↗ |
| K944270 | CIT MONOPOLAR LAPAROSCOPIC INSTRMENTS | Chirurgische Instrumente | 1995-07-25 | Traditional | PDF ↗ |
| K941206 | DUAL VALVE ASPIRATION/LAVAGE CANNULA AND ASPIRATION/SUCTION PROBE | New Eder Corp. | 1995-07-25 | Traditional | PDF ↗ |
| K951394 | KARL STORZ PEDIATRIC VANCAILLIE, MANHES TAKE-APART BIPOLAR FORCEPS, BIPOLAR COAGULATION ELECTRODE | KARL STORZ Endoscopy-America, Inc. | 1995-07-20 | Traditional | PDF ↗ |
| K950962 | KARL STORZ HOK NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT | KARL STORZ Endoscopy-America, Inc. | 1995-07-12 | Traditional | PDF ↗ |
| K946380 | NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V) | American Hydro-Surgical Instruments, Inc. | 1995-07-06 | Traditional | PDF ↗ |
| K943713 | TORCARS,CANNULAE,SHEATHS,OBTURATORS | Karl Storz Endoskop GmbH | 1995-06-30 | Traditional | PDF ↗ |
| K951190 | KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE | KARL STORZ Endoscopy-America, Inc. | 1995-06-14 | Traditional | PDF ↗ |
| K951490 | LASEVAC | D.D. Surgical, Inc. | 1995-06-13 | Traditional | PDF ↗ |
| K943662 | LAPARASCOPE | Pollux Endoscopy, Inc. | 1995-05-25 | Traditional | PDF ↗ |
| K946147 | KSE STEINER ELECTROMECHANIC MORCELLATOR | KARL STORZ Endoscopy-America, Inc. | 1995-05-25 | Traditional | PDF ↗ |
| K950108 | R-MED MINI-RETRACTOR | R-Med, Inc. | 1995-05-11 | Traditional | PDF ↗ |
| K946359 | KARL STORZ DILATION SET, REDUCERS, THREAD SLEEVES, DISTANCE HOLDERS | KARL STORZ Endoscopy-America, Inc. | 1995-05-11 | Traditional | PDF ↗ |
| K950457 | CANNUAL AND TROCAR, SUPERPUBIC | Core Dynamics, Inc. | 1995-05-05 | Traditional | PDF ↗ |
| K945685 | KARL STORZ TELESCOPE BRIDGES AND INSERTS, ADAPTERS | KARL STORZ Endoscopy-America, Inc. | 1995-05-05 | Traditional | PDF ↗ |
| K942730 | AESCULAP LAPAROSCOPES | Aesculap, Inc. | 1995-04-25 | Traditional | PDF ↗ |
| K942411 | R-MED DISPOSABLE PLUG | R-Med, Inc. | 1995-03-31 | Traditional | PDF ↗ |
| K945211 | KARL STORZ RETRACTORE, PROBES, DISSECTORS, HOOKS, UTERINEELEVATORS, UTERINE CANNULAE | KARL STORZ Endoscopy-America, Inc. | 1995-03-30 | Traditional | PDF ↗ |
| K943603 | AESCULAP LAPAROSCOPIC ANCILLARY DEVICES | Aesculap, Inc. | 1995-03-29 | Traditional | PDF ↗ |
| K945982 | KARL STORZ TAKE-APART(R) SUTURE FORCEPS, KNOT TIER | KARL STORZ Endoscopy-America, Inc. | 1995-03-21 | Traditional | PDF ↗ |
| K932779 | BIRTCHER SWIVEL GRIP LAPAROSCOPIC PROBES & ACCESS. | Birtcher Medical Systems, Inc. | 1995-03-21 | Traditional | PDF ↗ |
| K943053 | KSEA SEMM TISSUR PUNCH | Karl Storz Endoskop GmbH | 1995-03-21 | Traditional | PDF ↗ |
| K950232 | LAPAROSCOPE AND ACCESSORIES FOR OB/GYN | Olympus America, Inc. | 1995-03-16 | Traditional | PDF ↗ |
| K932387 | CONCEPTUS VARI-SOFT CATH/PIROUETTE POSIT MANDREL | Conceptus, Inc. | 1995-03-06 | Traditional | PDF ↗ |
| K941507 | THEMO-FLO SYSTEM 3 LAPAROSCOPIC/HYSTEROSCOPIC SYSTEM | Sanese Medical Corp. | 1995-03-06 | Traditional | PDF ↗ |
| K945741 | TROCAR AND CANNULA ACCESSORY | Applied Medical Resources | 1995-02-28 | Traditional | PDF ↗ |
| K932276 | CO2 HYDROMAT PUMP FOR IRRIGATION, MODEL #26310020 | KARL STORZ Endoscopy-America, Inc. | 1995-02-28 | Traditional | PDF ↗ |
| K942973 | HASSON STABILIZING ACCESS CANNULA (SAC) | Entec Corp. | 1995-02-27 | Traditional | PDF ↗ |
| K946235 | CONMED 7/8MM GASKET REDUCER FOR USE WITH TROGARD(TM) TROCAR SLEEVE | Conmedcorp | 1995-02-13 | Traditional | PDF ↗ |
| K943810 | IMAGYN MICROLAP INTRODUCER | Imagyn Medical, Inc. | 1995-01-26 | Traditional | PDF ↗ |
| K944268 | CIT TWO WAY SUCTIN AND IRRIGATION TUBES | Chirurgische Instrumente | 1995-01-26 | Traditional | PDF ↗ |
| K945100 | KARL STORZ SUCTION/IRRIGATION TUBES, CANNULAE | KARL STORZ Endoscopy-America, Inc. | 1995-01-24 | Traditional | PDF ↗ |
| K944269 | CIT GRASPING AND DISSECTING FORCEPS | Chirurgische Instrumente | 1995-01-24 | Traditional | PDF ↗ |
| K944079 | IMAGYN MICROLAP(TM) LAPAROSCOPE | Imagyn Medical, Inc. | 1995-01-20 | Traditional | PDF ↗ |
| K936273 | STEREO OPSIS CAMERA SYSTEM 3-D DISTAL CAM AND 3-D DISTAL CAM 360 | Baxter Healthcare Corp | 1995-01-06 | Traditional | PDF ↗ |
| K944555 | ENDOSCOPE | United States Surgical, A Division of Tyco Healthc | 1994-12-30 | Traditional | PDF ↗ |
| K944563 | FAMILY OF PRIMUS FORCEPS: GRASPERS/DISSECTORS/SUTURERS/NEEDLE DRIVERS | Marlow Surgical Technologies, Inc. | 1994-12-27 | Traditional | PDF ↗ |
| K934799 | CONMED TROGARD | Conmedcorp | 1994-12-21 | Traditional | PDF ↗ |
| K942447 | HASSON OPEN LAPAROSCOPY CANNULA | Linvatec Corp. | 1994-12-15 | Traditional | PDF ↗ |
| K931065 | LAPAROVIEW | Northgate Technologies, Inc. | 1994-11-30 | Traditional | PDF ↗ |
| K943508 | INSUFFLATOR TUBING WITH FILTER | Stryker Endoscopy | 1994-11-17 | Traditional | PDF ↗ |
| K944245 | DYNABITE LAPAROSCOPIC FORCEPS | Portlyn Corp. | 1994-11-15 | Traditional | PDF ↗ |
| K944129 | IMAGYN LAPAROSCOPIC INSTRUMENTS | Imagyn Medical, Inc. | 1994-10-20 | Traditional | PDF ↗ |
| K943598 | FLEXIBLE FIBER OPTIC LAPAROSCOPES | Optimed Technologies, Inc. | 1994-10-18 | Traditional | PDF ↗ |
| K931478 | ZEISS OPMI L STEREO-LAPAROSCOPE | Carl Zeiss, Inc. | 1994-09-28 | Traditional | PDF ↗ |
| K936011 | INVAMED REUSABLE LAPAROSCOPIC TROCAR SYSTEM | Invamed, Inc. | 1994-09-21 | Traditional | PDF ↗ |
| K926259 | SURGIMAT | W.O.M. World of Medicine GmbH | 1994-09-14 | Traditional | PDF ↗ |
| K925079 | LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER) | Endo Technic Corp. | 1994-08-24 | Traditional | PDF ↗ |
| K936071 | SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE | Smith & Nephew Dyonics, Inc. | 1994-08-19 | Traditional | PDF ↗ |
| K941944 | TAHOE SURGICAL INSTRUMENTS LIGATURE DEVICE | Tahoe Surgical Instruments P.R., Inc. | 1994-07-25 | Traditional | PDF ↗ |
| K940718 | INNERVISION INC. LAPAROSCOPIC HAND INSTRUMENTS | Innervision, Inc. | 1994-07-22 | Traditional | PDF ↗ |
| K921294 | VIDEO ENDOSCOPE-RIGID MODIFICATION | Medical Dynamics, Inc. | 1994-07-20 | Traditional | PDF ↗ |
| K926597 | LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) | Optimed Technologies, Inc. | 1994-07-12 | Traditional | PDF ↗ |
| K924611 | IRRIGATION PUMP AND TUBING SET | Marlo Surgical Technology | 1994-06-30 | Traditional | PDF ↗ |
| K933768 | COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES | Mahe-Medizintechnik | 1994-06-27 | Traditional | PDF ↗ |
| K940505 | ARTICULATING LAPAROSCOPIC RETRACOTOR (URESIL) | Uresil Corp. | 1994-06-21 | Traditional | PDF ↗ |
| K941208 | DIAGNOSTIC SLEEVE, REDUCER SLEEVE | New Eder Corp. | 1994-06-17 | Traditional | PDF ↗ |
| K941334 | DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE | Davol, Inc. | 1994-06-14 | Traditional | PDF ↗ |
| K926596 | OWENS ENDOSCOPIC INSTRUMENTS AND ACCESSORIES | Owens Industries, Inc. | 1994-06-10 | Traditional | PDF ↗ |
| K923260 | LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT CURVED | Imtec Corp. | 1994-06-09 | Traditional | PDF ↗ |
| K926594 | OWENS LAPAROSCOPY INSTRUMENTS AND ACCESSORIES | Owens Industries, Inc. | 1994-06-06 | Traditional | PDF ↗ |
| K940709 | SCISSORS, GRASPING FORCEPS, NEEDLE HOLDERS, DISSECTORS | Baxter Healthcare Corp | 1994-05-19 | Traditional | PDF ↗ |
| K935785 | KARL STORZ IRRIGATION AND SUCTION SYSTEM HANDPIECE AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | 1994-05-11 | Traditional | PDF ↗ |
| K941094 | INSUFFLATION TUBING & FILTER | H & C Chemical, Inc. | 1994-05-10 | Traditional | PDF ↗ |
| K940462 | HYDROMAT TRUMPET VALVE AND TUBING SET FOR LAPAROSCOPIC SUCTION AND IRRIGATION | KARL STORZ Endoscopy-America, Inc. | 1994-05-10 | Traditional | PDF ↗ |
| K940049 | KNOT PUSHER, SPOON FORCEPS AND BIOPSY FORCEPS | Baxter Healthcare Corp | 1994-05-06 | Traditional | PDF ↗ |
| K940844 | MYOMA DRILL 5MM-8383.611 | Richard Wolf Medical Instruments Corp. | 1994-05-02 | Traditional | PDF ↗ |
| K921722 | BARD(R) LEVENTHAL(TM) GYNE-FLO(TM) CANNULA | Bard Reproductive Systems | 1994-05-02 | Traditional | PDF ↗ |
| K925968 | ENDOSCOPE | United States Surgical, A Division of Tyco Healthc | 1994-04-28 | Traditional | PDF ↗ |
| K935031 | RIZA-RIBE NEEDLE | R-Med, Inc. | 1994-04-25 | Traditional | PDF ↗ |
| K931771 | BIRTCHER ENDOSCOPIC CORKSCREW | Birtcher Medical Systems, Inc. | 1994-04-25 | Traditional | PDF ↗ |
| K931654 | BIRTCHER MAGNETIC RETRIEVER (GS-3100) | Birtcher Medical Systems, Inc. | 1994-04-25 | Traditional | PDF ↗ |
| K941494 | ENDO-ASSIST LAPAROSCOPIC INSTRUMENTS | Sharpe Endosurgical Corp. | 1994-04-22 | Traditional | PDF ↗ |
| K923259 | LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT SHEARS | Imtec Corp. | 1994-04-11 | Traditional | PDF ↗ |
| K932689 | LAPRO-LOADER(TM) | Surgimark, Inc. | 1994-04-11 | Traditional | PDF ↗ |
| K926021 | NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE | Zinnanti Surgical Instruments, Inc. | 1994-04-07 | Traditional | PDF ↗ |
| K933492 | ESYS SYSTEM | Endolap, Inc. | 1994-03-25 | Traditional | PDF ↗ |
Product code HET · Class II · Obstetrics/Gynecology. Data: openFDA.