Review Panel
Obstetrics/Gynecology FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,626
- Product Codes (page)
- 35
- Latest Decision
- 1994-02-25
Clearances · page 32 of 47
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K926536 | DISPOSABLE PLASTIC VAGINAL SPECULA | Thomasville Medical Assoc. | HIB | Class II | 1994-02-25 |
| K926532 | ENDO CERVICAL CURETTE | Thomasville Medical Assoc. | KNA | Class II | 1994-02-25 |
| K926535 | GOMCO CIRCUMCISION CLAMP | Thomasville Medical Assoc. | HFX | Class II | 1994-02-25 |
| K926471 | MOGAN CIRCUMCISION CLAMP | Thomasville Medical Assoc. | HFX | Class II | 1994-02-25 |
| K926527 | ROTO FIT BIOPSY FORCEPS | Thomasville Medical Assoc. | HFB | Class I | 1994-02-25 |
| K930037 | ATRAUMATIC TENACULA | Thomasville Medical Assoc. | HDC | Class II | 1994-02-24 |
| K926528 | OVUM FORCEPS | Thomasville Medical Assoc. | HCZ | Class II | 1994-02-24 |
| K930727 | VARIOUS SCISSORS | Thomasville Medical Assoc. | KNA | Class II | 1994-02-24 |
| K930036 | THOMAS MEDICAL BIOPSY FORCEPS | Thomasville Medical Assoc. | HFB | Class I | 1994-02-24 |
| K930039 | FORCEPS: MCGRAVEY, MCINDOE, GILLIS | Thomasville Medical Assoc. | HCZ | Class II | 1994-02-24 |
| K926538 | TISCHLER BIOPSY FORCEPS | Thomasville Medical Assoc. | HFB | Class I | 1994-02-24 |
| K930799 | VARIOUS FORCEPS | Thomasville Medical Assoc. | HCZ | Class II | 1994-02-24 |
| K930110 | MICRO SURGERY NEEDLE HOLDERS | Thomasville Medical Assoc. | KNA | Class II | 1994-02-24 |
| K934662 | UNSCENTED MENSTRUAL PAD | Eldari, Ltd. | HHD | Class I | 1994-02-24 |
| K926530 | MIYA HOOK | Thomasville Medical Assoc. | KNA | Class II | 1994-02-24 |
| K926529 | Z CLAMP SCISSORS | Thomasville Medical Assoc. | KNA | Class II | 1994-02-24 |
| K926541 | IUD HOOKS | Thomasville Medical Assoc. | HHF | Class I | 1994-02-24 |
| K930031 | MICRO SURGERY SCISSORS | Thomasville Medical Assoc. | KNA | Class II | 1994-02-24 |
| K930034 | CERVICAL DILATORS:PRATT,HAWKIN,KLEEGMAN,DENNISTON | Thomasville Medical Assoc. | HDQ | Class I | 1994-02-24 |
| K935665 | INTRAUTERINE SOUND | Rocket of London, Ltd. | HHM | Class I | 1994-02-24 |
| K926537 | NEEDLE EXTENSIONS | Thomasville Medical Assoc. | KNA | Class II | 1994-02-24 |
| K923628 | CERVICAL LOOP ELECTRODE & ROLLERBALL ELECTRODE | Bruce Mclucas | HGI | Class II | 1994-02-22 |
| K924200 | REFLEX(R) ESC | Richard-Allan Medical Ind., Inc. | KNF | Class II | 1994-02-22 |
| K920514 | SPIRAL | Thornton Associates, Inc. | HIS | Class II | 1994-02-22 |
| K930038 | CANNULA: KAHN, JARCO, CORSON AND RATCHET | Thomasville Medical Assoc. | LKF | Class II | 1994-02-18 |
| K931994 | RESECTOSCOPE SHEATH | Olympus Corp. | HIH | Class II | 1994-02-17 |
| K935491 | CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER) | Tri-State Hospital Supply Corp. | HFX | Class II | 1994-02-17 |
| K922248 | MALLAWANY ATRAUMATIC TISSUE FORCEPS | Numed Technologies, Inc. | HET | Class II | 1994-02-17 |
| K931338 | 16 ELECTRODES (BLADE, BALL, NEEDLE & LOOP) | Aaron Medical Industries | HGI | Class II | 1994-02-16 |
| K934525 | AUTO SUTURE DISPOSABLE UMBILICAL CLIP APPLIER | United States Surgical, A Division of Tyco Healthc | HFW | Class II | 1994-02-14 |
| K930032 | RETRACTOR RODS | Thomasville Medical Assoc. | KNA | Class II | 1994-02-10 |
| K931561 | TROCAR SLEEVE | L.A.S.E.R., Inc. | HET | Class II | 1994-02-07 |
| K924224 | OWENS BIOPSY FORCEPS | Owens Precision Systems, Inc. | HFB | Class I | 1994-02-04 |
| K914541 | SPERM MAINTENANCE MEDIUM WITH GLYCEROL | Irvine Scientific | MFD | Class II | 1994-02-03 |
| K921335 | ULTRAFLOW SUCTION-IRRIGATION CANNULA | Endoscopic Surgical Products, Inc. | HET | Class II | 1994-02-03 |
| K930571 | REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING | Numed Technologies, Inc. | HFI | Class II | 1994-02-01 |
| K931606 | 7-510-25 HYSTEROMED TUBING KIT | Nortech | HIG | Class II | 1994-01-24 |
| K931501 | NUMED DISPOSABLE ATT. NUMED HANDLE LAP. INST. | Numed Technologies, Inc. | HET | Class II | 1994-01-11 |
| K932072 | JARIT SURGICAL INSTRUMENTS | Medical Device Inspection Co., Inc. | HET | Class II | 1994-01-11 |
| K931136 | APOLLO CAMERA | Life Sensing Instrument Company, Inc. | HET | Class II | 1994-01-11 |
| K932020 | ENTREE BLUNT TIP TROCAR AND ADAPTER | Core Dynamics, Inc. | HET | Class II | 1994-01-11 |
| K915844 | EXACT-TOUCH | Baal Assoc., Inc. | HHT | Class II | 1994-01-07 |
| K924177 | CONFORT | Scott Paper , Ltd. | HHD | Class I | 1993-12-23 |
| K923568 | TROCAR STABILITY THREAD | Applied Medical Resources | HET | Class II | 1993-12-23 |
| K924176 | SABA INTIMA | Scott Paper Co. | HHD | Class I | 1993-12-23 |
| K924175 | SABA CONFORT | Scott Paper Co. | HHD | Class I | 1993-12-23 |
| K912355 | MOTHERS TOUCH ONE HAND BREAST PUMP | Hollister, Inc. | HGY | Class I | 1993-12-10 |
| K924420 | MEDICAL DISPOSABLE BEDDING | Hill-Rom, Inc. | KNC | Class II | 1993-12-10 |
| K914544 | BD6000 THE OPTIMA & BD5000 BIRTHING BED | Lic Care, Inc. | KNC | Class II | 1993-11-24 |
| K921261 | ELECTRIC POWERED BREAST PUMP | Schuco, Inc. | HGX | Class II | 1993-11-09 |
| K921716 | DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM | American Surgical Instruments Corp. | HET | Class II | 1993-11-08 |
| K923636 | TROCAR W/ BLUNT TIP OBTURATOR | Applied Medical Resources | HET | Class II | 1993-11-05 |
| K920205 | OTT INSUFFLATION FILTER TUBING | Georgia Biomedical Research Group, Inc. | HIF | Class II | 1993-10-25 |
| K920838 | MEDSURG CIRCUMCISION TRAY | Medsurg Industries, Inc. | HFK | Class II | 1993-10-15 |
| K925572 | MITYVAC DISPOS-A-PLATE DISPOSABLE LEG PLATE | Neward Enterprises, Inc. | HGM | Class II | 1993-10-08 |
| K924844 | BULK TISSUE REMOVAL SYSTEM | L.A.S.E.R., Inc. | HET | Class II | 1993-10-08 |
| K921386 | SUOP ELECTRODES FOR EXCISIONAL PROCEDURES | Silver Creek Surgical | HGI | Class II | 1993-10-08 |
| K921417 | URESIL LAPAROSCOPIC RETRACTOR | Uresil Corp. | HET | Class II | 1993-10-08 |
| K923194 | INSUFFLATOR CONNECTING FILTER | Procedure Products, Inc. | HIF | Class II | 1993-10-08 |
| K923126 | MALLAWANY TISSUE GRASPING FORCEPS | Numed Technologies, Inc. | HET | Class II | 1993-10-08 |
| K920792 | SOFTCUP(TM):2 | Ultrafem, Inc. | HHE | Class II | 1993-10-05 |
| K922197 | INSUFFLATOR TUBING KIT | O.R. Concepts, Inc. | HIG | Class II | 1993-09-24 |
| K921956 | HEWLETT PACKARD MODEL M1353A FETAL MONITOR | Hewlett-Packard Co. | HGM | Class II | 1993-09-24 |
| K921957 | HEWLETT-PACKARD MODEL M1351A FETAL MONITOR | Hewlett-Packard Co. | HGM | Class II | 1993-09-24 |
| K922244 | INSUFFLATOR TUBING/FILTER KIT | O.R. Concepts, Inc. | HIF | Class II | 1993-09-24 |
| K925691 | INSUFFLATION TUBING | Mectra Labs, Inc. | HIF | Class II | 1993-09-23 |
| K914552 | CMI VACUUM PUMP | Columbia Medical & Surgical, Inc. | HDA | Class II | 1993-09-07 |
| K922206 | SURGISTAT | Valleylab, Inc. | HGI | Class II | 1993-09-07 |
| K923612 | MODIFIED F-10 CULTURE MEDIUM W/O HYPOXANTHINE | Life-Tech Intl., Inc. | MFD | Class II | 1993-09-07 |
| K923634 | MODIFIED F-10 CULTURE MEDIUM | Life-Tech Intl., Inc. | MFD | Class II | 1993-09-07 |
| K923651 | DISTILLED WATER | Life-Tech Intl., Inc. | MFD | Class II | 1993-09-07 |
| K923652 | DULBECCO'S PHOSPHATE BUFFERED SALINE | Life-Tech Intl., Inc. | MFD | Class II | 1993-09-07 |
| K911432 | ACCELLON CERVICAL BIOSAMPLER | Medscand AB | HHT | Class II | 1993-09-03 |
| K922245 | SUPER-FLOW TUBING | Armm, Inc. | HIF | Class II | 1993-09-03 |
| K914430 | NATRACARE TAMPON | Bodywise (Uk), Ltd. | HEB | Class II | 1993-09-03 |
| K914419 | AMNIOTEST(TM) | Pro-Lab, Inc. | HIO | Class I | 1993-09-01 |
| K922889 | CONDOOM SHELF LIFE -- MODIFICATIONS | Safetex Corp. | HIS | Class II | 1993-09-01 |
| K922834 | TAMPONS, NATURAL ODOR PROT. VARIOUS ABSORBENCY | Playtex Family Products, Inc. | HIL | Class II | 1993-09-01 |
| K920238 | PRIVATE LABELS AND FEMTEX | First Quality Hygienic, Inc. | HEB | Class II | 1993-08-02 |
| K923932 | TAMPAX TAMPONS, SUPER ABSORBENCY | Tambrands, Inc. | HEB | Class II | 1993-07-29 |
| K924303 | TAMPAX TAMPON, REGULAR ABSORBENCY | Tambrands, Inc. | HEB | Class II | 1993-07-29 |
| K922418 | VIDEO ENDOSCOPE SYSTEM | Baxter Healthcare Corp | HET | Class II | 1993-07-29 |
| K923143 | CYTO PAK PAP SMEAR KIT | International Medical Equipment Brokers, Inc. | HHT | Class II | 1993-07-16 |
| K924516 | OP3/VP4 | Huntleigh Technology, Inc. | HGL | Class II | 1993-06-28 |
| K920152 | BUBBLE TOCO | Utah Medical Products, Inc. | HFM | Class II | 1993-05-26 |
| K921015 | SHARPE ENDOSPONGE ASPIIRATOR | Paladin Medical, Inc. | HET | Class II | 1993-05-21 |
| K923439 | LUNEAU UMBILICAL CORD CLAMP | Laboratoires Luneau | HFW | Class II | 1993-05-21 |
| K921115 | ULTRA THIN MENSTRUAL PAD | Icd Products | HHD | Class I | 1993-05-21 |
| K924279 | PLAYTEX FLUSHABLE TAMPONS, REGULAR, SUPER, SUPER + | Playtex Family Products, Inc. | HIL | Class II | 1993-05-21 |
| K915743 | SHARPE ENDOTENACULUM | Paladin Medical, Inc. | HET | Class II | 1993-05-20 |
| K924908 | CELL COLLECTING BRUSH | Anderson Winn Paper Co. | HHT | Class II | 1993-04-13 |
| K925250 | KOTEX(R) SECUREHOLD SUPER CURVE/CURVED MAXI PADS | Kimberly-Clark Corp. | HHD | Class I | 1993-03-03 |
| K915779 | AFFINITY BED MODEL 3600 SERIES | Hill-Rom, Inc. | KNC | Class II | 1993-02-24 |
| K923985 | UNSCENTED MENSTRUAL TAMPON | Personal Products Co. | HEB | Class II | 1993-02-19 |
| K921837 | MEDICAM 900 INSUFFLATOR WITH ACCESSORIES | Kirschner Medical Corp. | HIF | Class II | 1993-02-05 |
| K920234 | DAVOL LAPAROSCOPIC DISSECTORS | C.R. Bard, Inc. | HET | Class II | 1993-02-05 |
| K924530 | CABOT MEDICAL NIAGARA(TM) 3.0 LITER HIGH FLOW IRRI | Cabot Medical Corp. | HET | Class II | 1993-02-05 |
| K922575 | ALWAYS CONTOURS UNSCENTED MENSTRUAL PADS | Procter & Gamble Co. | HHD | Class I | 1993-02-02 |
| K921884 | FORCE 2 | Valleylab, Inc. | HGI | Class II | 1992-12-15 |
| K920056 | POCKET SIZE FETAL HEART DETECTOR | Medical Accessories, Inc. | KNG | Class II | 1992-12-11 |
4,626 clearances in the Obstetrics/Gynecology panel. Data: openFDA.