Review Panel
Obstetrics/Gynecology FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,626
- Product Codes (page)
- 16
- Latest Decision
- 1977-02-01
Clearances · page 47 of 47
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K760888 | MODEL 6/60 CRT VIDEO-SONAR | Vexilar, Inc. | KNG | Class II | 1977-02-01 |
| K761347 | COLPOSCOPICALLY DIRECTED OB/GYN LASER | Photon Sources | HHR | Class II | 1977-01-18 |
| K761348 | CERVICAL-VAGINAL SPATULA | Law Offices of Natter & Natter | HHT | Class II | 1977-01-18 |
| K761338 | LEFF STETHOSCOPE FOR FETAL HEART | J. Sklar Mfg. Co., Inc. | HGN | Class I | 1977-01-12 |
| K761201 | ECHO-CARDIOTRACE, AUTOMATIC | Metrix Co. | HGM | Class II | 1977-01-12 |
| K760968 | CENTRAL STATION REPEATER (MODEL 8032A) | Hewlett-Packard Co. | KXN | Class II | 1976-12-17 |
| K761205 | DYNATECH JD7/JD7P COLPOSCOPE | Dynatech Cryomedical Co. | HEX | Class II | 1976-12-17 |
| K761233 | STAYFREE MAXI PADS | Personal Products Co. | HHL | Class II | 1976-12-17 |
| K761184 | RELY TAMPON | Procter & Gamble Mfg. Co. | HIL | Class II | 1976-12-17 |
| K761230 | AMMOCENTESIS TRAY (KIT) | Pharmaseal Div., Baxter Healthcare Corp. | HIO | Class I | 1976-12-17 |
| K761052 | REAL TIME OBSTETRICAL ULTRASONIC SCANNER | Smithkline Diagnostics, Inc. | HEM | Class II | 1976-12-16 |
| K760874 | V.I. OCTOSON ULTRASONIC SYSTEM | General Electric Co. | HEM | Class II | 1976-12-16 |
| K761139 | T-M (TIME-MOTION) OPTION | G.D. Searle and Co. | HGM | Class II | 1976-12-16 |
| K761030 | EKOSECTOR I | Smithkline Diagnostics, Inc. | HGM | Class II | 1976-12-13 |
| K760999 | THERMOGRAPH, MEDICAL | Honeywell, Inc. | IYM | Class III | 1976-11-19 |
| K760919 | MODEL 2106 FETA SONDE FETAL MONITOR | Roche Medical Electronics, Inc. | HGM | Class II | 1976-11-16 |
| K760911 | BREAST CARE KIT | American Hospital Supply Corp. | HGY | Class I | 1976-11-11 |
| K760924 | TUCKS POLYPAD MATERNITY CARE PAD | Parke-Davis Co. | HHD | Class I | 1976-11-11 |
| K760853 | STAYFREE DEODORANT MINI-PADS | Personal Products Co. | HHL | Class II | 1976-11-11 |
| K760763 | COLPOSCOPE (DYNATECH COLPOSCOPE-MODEL I | Dynatech Cryomedical Co. | HEX | Class II | 1976-10-20 |
| K760728 | CONTINUOUS WAVE DOPPLER ULTRASOUND | Medsonics | KNG | Class II | 1976-10-06 |
| K760264 | CURETTE, PROPOSED TIS-U-TRAP, METAL | Milex Products, Inc. | HHK | Class II | 1976-10-06 |
| K760425 | TAMPON, PLAYTEX 2 VERSION A | Intl. Playtex, Inc. | HIL | Class II | 1976-09-13 |
| K760426 | TAMPON, PLAYTEX 2 VERSION B | Intl. Playtex, Inc. | HIL | Class II | 1976-08-26 |
| K760455 | OBSTETRICAL PACK (VIGILON OB PACK) | C.R. Bard, Inc. | HHD | Class I | 1976-08-26 |
| K760170 | INTRAUTERINE SOUND, PLASTIC DISPOSABLE | G.D. Searle and Co. | HHM | Class I | 1976-07-19 |
4,626 clearances in the Obstetrics/Gynecology panel. Data: openFDA.