KOA — Surgical Instruments, G-U, Manual (And Accessories) Class I
FDA product code KOA covers "Surgical Instruments, G-U, Manual (And Accessories)", a Class I medical device regulated under 21 CFR 876.4730. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KOA
- Device Class
- Class I
- Regulation Number
- 876.4730
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K182664 | Agency For Medical Innovations | FiXcision | Dec 7, 2018 |
| K950267 | Applied Medical Resources | URETHRAL SUTURE GUIDE | Jan 31, 1995 |
| K932465 | Femcare | LI VASECTOMY | Mar 2, 1994 |
| K921546 | Cook Urological | VASOVASOSTOMY SET | Jul 2, 1993 |
| K931181 | Vesitec Medical | VESITEC SUTURE PASSER | May 12, 1993 |
| K921304 | North American Medical | DDV LIGATOR | Oct 5, 1992 |
| K922971 | Pilling | NO-SCALPEL VASCETOMY INSTRUMENTS | Sep 23, 1992 |
| K921228 | Eimark Labs | BENDEREV PROTECT-A-PASS NEEDLE | Sep 14, 1992 |
| K922192 | Cook Urological | VAS DILATOR | Aug 7, 1992 |
| K896058 | Annex Medical | GRASPING FORCEPS | Dec 28, 1989 |
| K891352 | Simpson/Basye | MARLOW ANAL SPECULUM | Jun 23, 1989 |
| K890218 | Kinetic Medical Products | MICROSURGICAL CYSTOTOME | Jan 27, 1989 |
| K864963 | Medovations | STOMACH EVACULATOR - EWALD STYLE | Oct 14, 1987 |
| K863273 | Martin Medical | MARTIN MEDICAL PRO-SCOPE ANOSCOPE | Nov 4, 1986 |
| K852014 | Effner And Spreine | EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA | Aug 7, 1985 |
| K852725 | Huxley Instrument | BABCOCK TISSUE FORCEPS, 6-1/4 + SS 410 OR 420 | Jul 9, 1985 |
| K852726 | Huxley Instrument | ALLIS TISSUE FORCEPS, 4X5 TEETH, 6+SS 410 OR 420 | Jul 9, 1985 |
| K851162 | Van-Tec | AL ASKARI PERCUTANEOUS ACCESS NEEDLE HOLDER | Apr 15, 1985 |
| K851111 | Huxley Instrument | RANDALL KIDNEY STONE FORCEPS 817-84 PCS. HALF CURV | Apr 3, 1985 |
| K851113 | Huxley Instrument | RANDALL KIDNEY STONE FORCEPS 817-144 PCS. FULL CUR | Apr 3, 1985 |