Product code KOA
- Device name
- Surgical Instruments, G-U, Manual (And Accessories)
- Medical specialty
- Gastroenterology, Urology
- Device class
- 1
- Regulation number
- 876.4730
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K182664 | FiXcision | Agency For Medical Innovations GmbH | 2018-12-07 |
| K950267 | URETHRAL SUTURE GUIDE | Applied Medical Resources | 1995-01-31 |
| K932465 | LI VASECTOMY | Femcare , Ltd. | 1994-03-02 |
| K921546 | VASOVASOSTOMY SET | Cook Urological, Inc. | 1993-07-02 |
| K931181 | VESITEC SUTURE PASSER | Vesitec Medical, Inc. | 1993-05-12 |
| K921304 | DDV LIGATOR | North American Medical, Inc. | 1992-10-05 |
| K922971 | NO-SCALPEL VASCETOMY INSTRUMENTS | Pilling Co. | 1992-09-23 |
| K921228 | BENDEREV PROTECT-A-PASS NEEDLE | Eimark Labs, Inc. | 1992-09-14 |
| K922192 | VAS DILATOR | Cook Urological, Inc. | 1992-08-07 |
| K896058 | GRASPING FORCEPS | Annex Medical, Inc. | 1989-12-28 |
| K891352 | MARLOW ANAL SPECULUM | Simpson/Basye, Inc. | 1989-06-23 |
| K890218 | MICROSURGICAL CYSTOTOME | Kinetic Medical Products | 1989-01-27 |
| K864963 | STOMACH EVACULATOR - EWALD STYLE | Medovations, Inc. | 1987-10-14 |
| K863273 | MARTIN MEDICAL PRO-SCOPE ANOSCOPE | Martin Medical | 1986-11-04 |
| K852014 | EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA | Effner and Spreine Co. | 1985-08-07 |
| K852726 | ALLIS TISSUE FORCEPS, 4X5 TEETH, 6+SS 410 OR 420 | The Huxley Instrument Corp. | 1985-07-09 |
| K852725 | BABCOCK TISSUE FORCEPS, 6-1/4 + SS 410 OR 420 | The Huxley Instrument Corp. | 1985-07-09 |
| K851162 | AL ASKARI PERCUTANEOUS ACCESS NEEDLE HOLDER | Van-Tec, Inc. | 1985-04-15 |
| K851113 | RANDALL KIDNEY STONE FORCEPS 817-144 PCS. FULL CUR | The Huxley Instrument Corp. | 1985-04-03 |
| K851111 | RANDALL KIDNEY STONE FORCEPS 817-84 PCS. HALF CURV | The Huxley Instrument Corp. | 1985-04-03 |
| K851112 | RANDALL KIDNEY STONE FORCEPS 817-144 PCS. QUARTER | The Huxley Instrument Corp. | 1985-04-03 |
| K841387 | WESTON RECTAL SNARE | Imm Enterprises , Ltd. | 1984-05-09 |
| K834171 | OP-CON SURG. INSTRUMENT #3 | Imm Enterprises , Ltd. | 1984-04-04 |
| K834191 | JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 | Imm Enterprises , Ltd. | 1984-03-22 |
| K834192 | JAKOBI SURG. INSTRUMENTS #3 21/22/24 | Imm Enterprises , Ltd. | 1984-03-22 |
| K841003 | PROBES, VARIOUS | Premier Dental Products Co. | 1984-03-20 |
| K832677 | P-S MEDICAL BERLIN VISADUCT KIT | Pudenz-Schulte Medical Research Corp. | 1983-12-08 |
| K830786 | DISIMETRIC RELEASE OF INSTRANETICS RAD | American Convertors Div., American Pharmaseal | 1983-05-18 |
| K822401 | ST. MARK'S RECTAL BIOPSY FORCEPS | Keymed, Inc. | 1982-08-27 |
| K820015 | URETHAL CUTTER CLAMP | Lone Star Medical Products, Inc. | 1982-02-22 |
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| 10198956045200 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2025-05-22 |
| 10197106774748 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-10-01 |
| 10197106619582 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-03-28 |
| 10197106466513 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2023-10-25 |
| 10197106362105 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2023-10-12 |
| 10197106277584 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2023-08-31 |
| 10197106362150 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2023-08-10 |
| 10195327463809 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2023-07-23 |
| 10197106329214 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2023-06-26 |
| 10197106220757 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2023-04-13 |
| 07898506814671 | Quinelato | Schobell Industrial Ltda | 2022-12-20 |
| 07898506814640 | Quinelato | Schobell Industrial Ltda | 2022-12-20 |
| 07898506814497 | Quinelato | Schobell Industrial Ltda | 2022-12-20 |
| 07898506814473 | Quinelato | Schobell Industrial Ltda | 2022-12-20 |
| 10195594734718 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-07-21 |
| 10195594460068 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-02-01 |
| 10195594460075 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-01-24 |
| 08714729904458 | Steerable Stent Positioner | BOSTON SCIENTIFIC CORPORATION | 2017-11-03 |
| 08714729904441 | Steerable Stent Positioner | BOSTON SCIENTIFIC CORPORATION | 2017-11-03 |
| 08714729904434 | Steerable Stent Positioner | BOSTON SCIENTIFIC CORPORATION | 2017-11-03 |
| 08714729904427 | Steerable Stent Positioner | BOSTON SCIENTIFIC CORPORATION | 2017-11-03 |
| 10801334000349 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |
| 10801334004507 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |
| 10801334007690 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |
| 08714729751496 | NA | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751489 | NA | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751472 | NA | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729751465 | NA | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |