FDA product code KOA: Surgical Instruments, G-U, Manual (And Accessories)
KOA is the FDA product code for surgical instruments, g-u, manual (and accessories). It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 44 510(k) submissions under KOA, from 31 different applicants. The average 510(k) review took 75 days (median 42). FDA has posted 6 recalls for KOA devices.
Classification
| Field | Value |
|---|---|
| Device name | Surgical Instruments, G-U, Manual (And Accessories) |
| Device class | Class I |
| Regulation | 21 CFR 876.4730 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for KOA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 73 |
Compare with all 510(k) review times · Search every KOA clearance
Top KOA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Huxley Instrument Corp. | 5 | 1985-07-09 |
| Imm Enterprises , Ltd. | 4 | 1984-05-09 |
| Lone Star Medical Products, Inc. | 3 | 1982-02-22 |
| V. Mueller O.V. Baxter Healthcare Corp. | 3 | 1976-10-21 |
| Cook Urological, Inc. | 2 | 1993-07-02 |
26 more applicants have KOA clearances. See the full list in Caduvo.
Most recent KOA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K182664 | Agency For Medical Innovations GmbH | FiXcision | 2018-12-07 | 73 |
| K950267 | Applied Medical Resources | URETHRAL SUTURE GUIDE | 1995-01-31 | 8 |
| K932465 | Femcare , Ltd. | LI VASECTOMY | 1994-03-02 | 285 |
| K921546 | Cook Urological, Inc. | VASOVASOSTOMY SET | 1993-07-02 | 457 |
| K931181 | Vesitec Medical, Inc. | VESITEC SUTURE PASSER | 1993-05-12 | 64 |
Recalls for KOA devices
6 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-04-01.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2019 | 1 |
| 2020 | 2 |
Frequently asked questions
What is FDA product code KOA?
KOA is the FDA product code for surgical instruments, g-u, manual (and accessories). It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel.
What device class is KOA?
Class I, regulation 21 CFR 876.4730. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KOA?
Across 44 cleared submissions the average was 75 days from receipt to decision (median 42).
Which companies have the most KOA clearances?
The Huxley Instrument Corp. (5); Imm Enterprises , Ltd. (4); Lone Star Medical Products, Inc. (3); V. Mueller O.V. Baxter Healthcare Corp. (3); Cook Urological, Inc. (2).
Have KOA devices been recalled?
Yes: 6 product recalls across 3 recall events; the most recent began 2020-04-01.
Next steps
- Run an FDA pathway report with predicate devices for product code KOA
- Run a recall and safety report across every KOA manufacturer
- Watch product code KOA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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