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 3 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K934506 | DYNABITE HYSTEROSCOPIC FORCEPS | Portlyn Corp. | 1994-03-22 | Traditional | PDF ↗ |
| K932118 | ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET | Core Dynamics, Inc. | 1994-03-17 | Traditional | PDF ↗ |
| K933130 | TROGARD TROCAR SLEEVE RETAINING THREAD | Conmedcorp | 1994-03-17 | Traditional | PDF ↗ |
| K934451 | HASSON 360 SERIES ENDOSCOPIC GRASPING FORCEPS | Cook Urological, Inc. | 1994-03-17 | Traditional | PDF ↗ |
| K933698 | 100 SERIES ENDOSCOPIC GRASPING FORCEPS | Cook Urological, Inc. | 1994-03-17 | Traditional | PDF ↗ |
| K930934 | ENDOPATH RELOADABLE LINEAR CUTTER | ETHICON, Inc. | 1994-03-11 | Traditional | PDF ↗ |
| K915857 | FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE | Olympus Corp. | 1994-03-11 | Traditional | PDF ↗ |
| K933008 | RETRACTORS AND SCRAPER | Baxter Healthcare Corp | 1994-03-11 | Traditional | PDF ↗ |
| K930756 | LAPAROSCOPIC IRRIGATION/ASPIRATION HANDPIECE | Endo Technic Corp. | 1994-03-09 | Traditional | PDF ↗ |
| K924485 | LAPAROSCOPY SET | Owens Precision Systems, Inc. | 1994-03-09 | Traditional | PDF ↗ |
| K932832 | PRIMUS INSULATED FORCEPS | Marlo Surgical Technology | 1994-02-25 | Traditional | PDF ↗ |
| K932634 | NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURES | Marlo Surgical Technology | 1994-02-25 | Traditional | PDF ↗ |
| K922248 | MALLAWANY ATRAUMATIC TISSUE FORCEPS | Numed Technologies, Inc. | 1994-02-17 | Traditional | PDF ↗ |
| K931561 | TROCAR SLEEVE | L.A.S.E.R., Inc. | 1994-02-07 | Traditional | PDF ↗ |
| K921335 | ULTRAFLOW SUCTION-IRRIGATION CANNULA | Endoscopic Surgical Products, Inc. | 1994-02-03 | Traditional | PDF ↗ |
| K931136 | APOLLO CAMERA | Life Sensing Instrument Company, Inc. | 1994-01-11 | Traditional | PDF ↗ |
| K932072 | JARIT SURGICAL INSTRUMENTS | Medical Device Inspection Co., Inc. | 1994-01-11 | Traditional | PDF ↗ |
| K932020 | ENTREE BLUNT TIP TROCAR AND ADAPTER | Core Dynamics, Inc. | 1994-01-11 | Traditional | PDF ↗ |
| K931501 | NUMED DISPOSABLE ATT. NUMED HANDLE LAP. INST. | Numed Technologies, Inc. | 1994-01-11 | Traditional | PDF ↗ |
| K923568 | TROCAR STABILITY THREAD | Applied Medical Resources | 1993-12-23 | Traditional | PDF ↗ |
| K921716 | DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM | American Surgical Instruments Corp. | 1993-11-08 | Traditional | PDF ↗ |
| K923636 | TROCAR W/ BLUNT TIP OBTURATOR | Applied Medical Resources | 1993-11-05 | Traditional | PDF ↗ |
| K921417 | URESIL LAPAROSCOPIC RETRACTOR | Uresil Corp. | 1993-10-08 | Traditional | PDF ↗ |
| K924844 | BULK TISSUE REMOVAL SYSTEM | L.A.S.E.R., Inc. | 1993-10-08 | Traditional | PDF ↗ |
| K923126 | MALLAWANY TISSUE GRASPING FORCEPS | Numed Technologies, Inc. | 1993-10-08 | Traditional | PDF ↗ |
| K922418 | VIDEO ENDOSCOPE SYSTEM | Baxter Healthcare Corp | 1993-07-29 | Traditional | PDF ↗ |
| K921015 | SHARPE ENDOSPONGE ASPIIRATOR | Paladin Medical, Inc. | 1993-05-21 | Traditional | PDF ↗ |
| K915743 | SHARPE ENDOTENACULUM | Paladin Medical, Inc. | 1993-05-20 | Traditional | PDF ↗ |
| K924530 | CABOT MEDICAL NIAGARA(TM) 3.0 LITER HIGH FLOW IRRI | Cabot Medical Corp. | 1993-02-05 | Traditional | PDF ↗ |
| K920234 | DAVOL LAPAROSCOPIC DISSECTORS | C.R. Bard, Inc. | 1993-02-05 | Traditional | PDF ↗ |
| K915749 | SHARPE ENDOLIGATURE CARRIER | Paladin Medical, Inc. | 1992-10-20 | Traditional | PDF ↗ |
| K915747 | SHARPE ENDOFORCEPS | Paladin Medical, Inc. | 1992-10-20 | Traditional | PDF ↗ |
| K921888 | SHARPE ENDODISSECTOR | Paladin Medical, Inc. | 1992-10-20 | Traditional | PDF ↗ |
| K915744 | SHARPE ENDOHEMOSTAT | Paladin Medical, Inc. | 1992-10-20 | Traditional | PDF ↗ |
| K915331 | AUTO SUTURE SURGIPORT DISPOSABLE ANCHORING DEVICE | United States Surgical, A Division of Tyco Healthc | 1992-09-29 | Traditional | PDF ↗ |
| K915338 | CONDUCTIVE SURGIGRIP SPIRAL SLEEVE | United States Surgical, A Division of Tyco Healthc | 1992-09-28 | Traditional | PDF ↗ |
| K920549 | SHARPE ENDONEEDLE HOLDER | Paladin Medical, Inc. | 1992-09-22 | Traditional | PDF ↗ |
| K920548 | SHARPE ENDOSCALPEL | Paladin Medical, Inc. | 1992-09-22 | Traditional | PDF ↗ |
| K914923 | UNISURGE DISPOSABLE TROCAR | Unisurge, Inc. | 1992-09-21 | Traditional | PDF ↗ |
| K915378 | WECK TROCAR | Edward Weck, Inc. | 1992-06-29 | Traditional | PDF ↗ |
| K915116 | TROCAR SHEATH ANCHOR | Origin Medsystems, Inc. | 1992-06-12 | Traditional | PDF ↗ |
| K912093 | DISPOSABLE ASPIRATION IRRIGATION SYSTEM | Applied Urology, Inc. | 1992-04-24 | Traditional | PDF ↗ |
| K913944 | NEZHAT/DORSEY HYDRO DISSECTION PUMP & ACCESSORIES | American Surgical Instruments Corp. | 1992-03-09 | Traditional | PDF ↗ |
| K913299 | SOF-FLEX LAPAROSCOPIC BASKET | Cook Ob/Gyn | 1992-02-14 | Traditional | PDF ↗ |
| K915297 | TROCAR & TROCAR SLEEEVE 11MM, 10MM, 8MM & 5MM | Lifeguard Medical Products, Inc. | 1992-02-11 | Traditional | PDF ↗ |
| K903663 | MEDSCOPE 8MM AND 10MM LAPAROSCOPE | Medscope Corp. | 1992-02-11 | Traditional | PDF ↗ |
| K914968 | DISPOSABLE TROCAR SLEEVE WITH DILATING OBTURATOR | ETHICON, Inc. | 1992-02-03 | Traditional | PDF ↗ |
| K912882 | INNERVISION LAPAROSCOPE AND ACCESSORIES | M.D. Engineering, Inc. | 1992-01-24 | Traditional | PDF ↗ |
| K912398 | ENDOPATH SURG DISP TROCAR(SHIELD/UNSHIELDED),MODIF | ETHICON, Inc. | 1991-12-17 | Traditional | PDF ↗ |
| K910921 | AUTO SUTURE SURGIPORT TISSUE GRIP DISPOSABLE SLEEV | United States Surgical, A Division of Tyco Healthc | 1991-08-26 | Traditional | PDF ↗ |
| K910907 | PUMP VAC PLUS | Marlo Surgical Technology | 1991-05-13 | Traditional | PDF ↗ |
| K905471 | TROCAR ACCESS SHEATH | Cook Ob/Gyn | 1991-05-09 | Traditional | PDF ↗ |
| K910209 | LAPAROSCOPIC IRRIGATOR/ASPIRATOR | Solos Mfg. | 1991-04-29 | Traditional | PDF ↗ |
| K904848 | PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE | Origin Medsystems, Inc. | 1991-04-08 | Traditional | PDF ↗ |
| K910015 | CANNULA INTRODUCTION SET | Lazarus Medical, Inc. | 1991-04-02 | Traditional | PDF ↗ |
| K910008 | ENDOTHRED ADJUSTABLE STABILITLY THEREAD | ETHICON, Inc. | 1991-03-21 | Traditional | PDF ↗ |
| K910713 | FLYNN TISSUE PROBE AND BLUNT DISSECTOR | Marlo Surgical Technology | 1991-03-21 | Traditional | PDF ↗ |
| K905759 | HASSON STABILIZING ACCESS CANNULA FOR OPEN LAPAROS | Marlo Surgical Technology | 1991-03-06 | Traditional | PDF ↗ |
| K903339 | VIDEO ENDOSCOPE, RIGID | Medical Dynamics, Inc. | 1991-03-06 | Traditional | PDF ↗ |
| K902197 | FUJINON EVL-F (TENTATIVE) AND TROCAR | Fujinon, Inc. | 1991-03-05 | Traditional | PDF ↗ |
| K905196 | LAPAROSCOPE | Baxter Healthcare Corp | 1991-03-04 | Traditional | PDF ↗ |
| K910579 | OVARIAN ASPIRATION/IRRIGATION NEEDLE | Marlo Surgical Technology | 1991-02-28 | Traditional | PDF ↗ |
| K910340 | LAPAROSCOPIC ASPIRATION PROBE | Davol, Inc. | 1991-02-26 | Traditional | PDF ↗ |
| K904645 | HALL TRANSCEERVICAL SAFE ACCESS CANNULA(TM) | Hall Medical Laboratories | 1991-02-26 | Traditional | PDF ↗ |
| K905426 | AUTO SUTURE MODIFIED ENDO STREAM SUC./IRRI. DEVICE | United States Surgical, A Division of Tyco Healthc | 1991-02-11 | Traditional | PDF ↗ |
| K904907 | ENDOPATH DISPOSABLE SURGICAL TROCAR REDUCER | ETHICON, Inc. | 1991-01-24 | Traditional | PDF ↗ |
| K904379 | SURGICAL TROCAR AND CANNULA | Applied Vascular Devices, Inc. | 1990-12-21 | Traditional | PDF ↗ |
| K903078 | HASSON STABILIZING ACCESS CANNULA | Marlo Surgical Technology | 1990-12-17 | Traditional | PDF ↗ |
| K904173 | INSULATED ELECTRODES AND LAPAROSCOPIC PROBICS | Baxter Healthcare Corp | 1990-12-10 | Traditional | PDF ↗ |
| K904143 | V. MUELLER TROCARS/TROCAR SLEEVES & NEEDLES | Baxter Healthcare Corp | 1990-12-06 | Traditional | PDF ↗ |
| K904104 | ENDOPATH UNSHIELDED DISPOSABLE SURGICAL TROCAR | ETHICON, Inc. | 1990-12-05 | Traditional | PDF ↗ |
| K904142 | GRASPING FORCEPS/ALIGATOR FORCEPS/NEEDLE HOLDERS | Baxter Healthcare Corp | 1990-12-05 | Traditional | PDF ↗ |
| K902722 | BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM | Davol, Inc. | 1990-11-16 | Traditional | PDF ↗ |
| K903560 | CLARKE LAPAROSCOPIC LIGATOR AND FORCEPS | Marlo Surgical Technology | 1990-11-06 | Traditional | PDF ↗ |
| K903780 | AUTO SUTURE LAPAROSCOPY ACCESSORY KIT | United States Surgical, A Division of Tyco Healthc | 1990-10-23 | Traditional | PDF ↗ |
| K903206 | AUTO SUTURE(R) ENDOSCOPIC SCISSORS | United States Surgical, A Division of Tyco Healthc | 1990-10-17 | Traditional | PDF ↗ |
| K903600 | ESPI MICRO GRASPER,DOUBLE-ACTION,INSULATED,#8250-N | Dixon Medical, Inc. | 1990-10-17 | Traditional | PDF ↗ |
| K903598 | ESPI DOUBLE-ACTION GRASPER, INSULATED, #8202-N | Dixon Medical, Inc. | 1990-10-17 | Traditional | PDF ↗ |
| K903599 | ESPI DOUBLE-ACTION INSULATED GRASPER, #8203-N | Dixon Medical, Inc. | 1990-10-17 | Traditional | PDF ↗ |
| K903187 | LAPAROSCOPIC CATHERTER | Cook Ob/Gyn | 1990-10-12 | Traditional | PDF ↗ |
| K903124 | LAPAROSCOPIC ACCESS SHEATH SET | Cook, Inc. | 1990-10-12 | Traditional | PDF ↗ |
| K903207 | AUTO SUTURE ENDOSCOPIC SUCTION/IRRIGATRION DEVICE | United States Surgical, A Division of Tyco Healthc | 1990-09-25 | Traditional | PDF ↗ |
| K902258 | 5 MM IRRIGATION/ASPIRATION FIBER PROBE | Hgm Medical Laser Systems, Inc. | 1990-09-19 | Traditional | PDF ↗ |
| K902657 | GYNESCOPE LAPAROSCOPIC FORCEPS | Gynescope Corp. | 1990-09-19 | Traditional | PDF ↗ |
| K903595 | ESPI CLAW FORCEP, #8302, 10MM, 30CM | Dixon Medical, Inc. | 1990-09-12 | Traditional | PDF ↗ |
| K903591 | ESPI HOOK/UNIVERSAL SCISSORS, # 8101 | Dixon Medical, Inc. | 1990-09-12 | Traditional | PDF ↗ |
| K903593 | ESPI APPLICATOR SLEEVE, #8410 | Dixon Medical, Inc. | 1990-09-12 | Traditional | PDF ↗ |
| K903596 | ESPI REDUCER SLEEVE, #8415 | Dixon Medical, Inc. | 1990-09-12 | Traditional | PDF ↗ |
| K903602 | ESPI NON-INSULATED DOUBLE-ACTION GRASPER, #8203 | Dixon Medical, Inc. | 1990-09-12 | Traditional | PDF ↗ |
| K903594 | ESPI TISSUE GRASPER/NEEDLE HOLDER, #8201 | Dixon Medical, Inc. | 1990-09-12 | Traditional | PDF ↗ |
| K903597 | ESPI MICRO SCISSORS, #8150 | Dixon Medical, Inc. | 1990-09-12 | Traditional | PDF ↗ |
| K903601 | ESPI NON-INSULATED DOUBLE-ACTION GRASPER #8204 | Dixon Medical, Inc. | 1990-09-12 | Traditional | PDF ↗ |
| K903592 | ESPI CLAW FORCEP, #8301, 5MM, 30 CM LENGTH | Dixon Medical, Inc. | 1990-09-12 | Traditional | PDF ↗ |
| K896524 | SPIRTOS COAXIAL CATHETER SET | Cook Ob/Gyn | 1990-09-05 | Traditional | PDF ↗ |
| K902563 | MONOSCOPY(TM) BRAND, TROCAR REDUCER SET | Dexide, Inc. | 1990-09-04 | Traditional | PDF ↗ |
| K903528 | LAPAROSCOPE | Intramed Laboratories, Inc. | 1990-09-04 | Traditional | PDF ↗ |
| K902655 | GYNESCOPE LAPAROSCOPES | Gynescope Corp. | 1990-07-13 | Traditional | PDF ↗ |
| K902656 | GYNESCOPE LAPAROSCOPIC TROCARS AND SLEEVES | Gynescope Corp. | 1990-06-29 | Traditional | PDF ↗ |
| K901407 | CORE DISPOSABLE TROCARS | Core Dynamics, Inc. | 1990-06-08 | Traditional | PDF ↗ |
| K900988 | AMCATH SUCTION-IRRIGATION TUBE | Intl. Medical, Inc. | 1990-05-07 | Traditional | PDF ↗ |
Product code HET · Class II · Obstetrics/Gynecology. Data: openFDA.