FDA Product Code
FDA Product Code KOA — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.4730
510(k) Clearances — 44 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K182664 | FiXcision | Agency For Medical Innovations GmbH | 2018-12-07 | Traditional | PDF ↗ |
| K950267 | URETHRAL SUTURE GUIDE | Applied Medical Resources | 1995-01-31 | Traditional | PDF ↗ |
| K932465 | LI VASECTOMY | Femcare , Ltd. | 1994-03-02 | Traditional | PDF ↗ |
| K921546 | VASOVASOSTOMY SET | Cook Urological, Inc. | 1993-07-02 | Traditional | PDF ↗ |
| K931181 | VESITEC SUTURE PASSER | Vesitec Medical, Inc. | 1993-05-12 | Traditional | PDF ↗ |
| K921304 | DDV LIGATOR | North American Medical, Inc. | 1992-10-05 | Traditional | PDF ↗ |
| K922971 | NO-SCALPEL VASCETOMY INSTRUMENTS | Pilling Co. | 1992-09-23 | Traditional | PDF ↗ |
| K921228 | BENDEREV PROTECT-A-PASS NEEDLE | Eimark Labs, Inc. | 1992-09-14 | Traditional | PDF ↗ |
| K922192 | VAS DILATOR | Cook Urological, Inc. | 1992-08-07 | Traditional | PDF ↗ |
| K896058 | GRASPING FORCEPS | Annex Medical, Inc. | 1989-12-28 | Traditional | PDF ↗ |
| K891352 | MARLOW ANAL SPECULUM | Simpson/Basye, Inc. | 1989-06-23 | Traditional | PDF ↗ |
| K890218 | MICROSURGICAL CYSTOTOME | Kinetic Medical Products | 1989-01-27 | Traditional | PDF ↗ |
| K864963 | STOMACH EVACULATOR - EWALD STYLE | Medovations, Inc. | 1987-10-14 | Traditional | PDF ↗ |
| K863273 | MARTIN MEDICAL PRO-SCOPE ANOSCOPE | Martin Medical | 1986-11-04 | Traditional | PDF ↗ |
| K852014 | EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA | Effner and Spreine Co. | 1985-08-07 | Traditional | PDF ↗ |
| K852725 | BABCOCK TISSUE FORCEPS, 6-1/4 + SS 410 OR 420 | The Huxley Instrument Corp. | 1985-07-09 | Traditional | PDF ↗ |
| K852726 | ALLIS TISSUE FORCEPS, 4X5 TEETH, 6+SS 410 OR 420 | The Huxley Instrument Corp. | 1985-07-09 | Traditional | PDF ↗ |
| K851162 | AL ASKARI PERCUTANEOUS ACCESS NEEDLE HOLDER | Van-Tec, Inc. | 1985-04-15 | Traditional | PDF ↗ |
| K851113 | RANDALL KIDNEY STONE FORCEPS 817-144 PCS. FULL CUR | The Huxley Instrument Corp. | 1985-04-03 | Traditional | PDF ↗ |
| K851111 | RANDALL KIDNEY STONE FORCEPS 817-84 PCS. HALF CURV | The Huxley Instrument Corp. | 1985-04-03 | Traditional | PDF ↗ |
| K851112 | RANDALL KIDNEY STONE FORCEPS 817-144 PCS. QUARTER | The Huxley Instrument Corp. | 1985-04-03 | Traditional | PDF ↗ |
| K841387 | WESTON RECTAL SNARE | Imm Enterprises , Ltd. | 1984-05-09 | Traditional | PDF ↗ |
| K834171 | OP-CON SURG. INSTRUMENT #3 | Imm Enterprises , Ltd. | 1984-04-04 | Traditional | PDF ↗ |
| K834191 | JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 | Imm Enterprises , Ltd. | 1984-03-22 | Traditional | PDF ↗ |
| K834192 | JAKOBI SURG. INSTRUMENTS #3 21/22/24 | Imm Enterprises , Ltd. | 1984-03-22 | Traditional | PDF ↗ |
| K841003 | PROBES, VARIOUS | Premier Dental Products Co. | 1984-03-20 | Traditional | PDF ↗ |
| K832677 | P-S MEDICAL BERLIN VISADUCT KIT | Pudenz-Schulte Medical Research Corp. | 1983-12-08 | Traditional | PDF ↗ |
| K830786 | DISIMETRIC RELEASE OF INSTRANETICS RAD | American Convertors Div., American Pharmaseal | 1983-05-18 | Traditional | PDF ↗ |
| K822401 | ST. MARK'S RECTAL BIOPSY FORCEPS | Keymed, Inc. | 1982-08-27 | Traditional | PDF ↗ |
| K820015 | URETHAL CUTTER CLAMP | Lone Star Medical Products, Inc. | 1982-02-22 | Traditional | PDF ↗ |
| K813504 | ACESSORY TO MODIFIED FREEDING JEJUNOSTO | Midwest Metabolic Support Group | 1982-01-07 | Traditional | PDF ↗ |
| K811973 | FORDER RETRACTOR | Surgemed Marketing, Inc. | 1981-07-31 | Traditional | PDF ↗ |
| K811693 | FORDER RETRACTOR | Dacomed Corp. | 1981-06-26 | Traditional | PDF ↗ |
| K811223 | VASOVASOSTOMY STABILIZER PLATFORM DEV | Biomet, Inc. | 1981-05-21 | Traditional | PDF ↗ |
| K810915 | THE SCOTT DIALMENZENSERT | Lone Star Medical Products, Inc. | 1981-05-08 | Traditional | PDF ↗ |
| K810533 | CIRCLE NEPHROSTOMY TUBE INTRODUCER | American V. Mueller | 1981-03-11 | Traditional | PDF ↗ |
| K802983 | THE INQUINAL RESORVOIR INSERTER | Lone Star Medical Products, Inc. | 1980-12-30 | Traditional | PDF ↗ |
| K801273 | MAGILL CATHETER INTRO. FORCEPS | J. Sklar Mfg. Co., Inc. | 1980-07-28 | Traditional | PDF ↗ |
| K800441 | RUDD-CLINIC HEMORRHOIDAL FORCEPS | J. Sklar Mfg. Co., Inc. | 1980-04-08 | Traditional | PDF ↗ |
| K772134 | SYRINGE, IRRIGATION, PRE-FILLED | Kendall Research Center | 1977-11-28 | Traditional | PDF ↗ |
| K761229 | ANAL/RECTAL SYRINGE | Ace Orthopedic Manufacturing Co. | 1977-02-24 | Traditional | PDF ↗ |
| K760717 | FLEXIBLE BIOPSY FORCEPS | V. Mueller O.V. Baxter Healthcare Corp. | 1976-10-21 | Traditional | PDF ↗ |
| K760715 | FLEXIBLE CUTTING SCISSORS | V. Mueller O.V. Baxter Healthcare Corp. | 1976-10-21 | Traditional | PDF ↗ |
| K760716 | FLEXIBLE FOREIGN BODY FORCEPS | V. Mueller O.V. Baxter Healthcare Corp. | 1976-10-15 | Traditional | PDF ↗ |
Product code KOA · Class I · Gastroenterology, Urology. Data: openFDA.