FDA product code KOH: Instrument, Manual, General Obstetric-Gynecologic
KOH is the FDA product code for instrument, manual, general obstetric-gynecologic. It is a Class I device, regulated under 21 CFR 884.4520 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 15 510(k) submissions under KOH, from 12 different applicants. The average 510(k) review took 159 days (median 70). FDA has posted 2 recalls for KOH devices.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Manual, General Obstetric-Gynecologic |
| Device class | Class I |
| Regulation | 21 CFR 884.4520 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KOH clearance
Top KOH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zinnanti Surgical Instruments, Inc. | 3 | 1989-05-11 |
| Medikmark, Inc. | 2 | 1994-06-15 |
| KARL STORZ Endoscopy-America, Inc. | 1 | 2000-04-21 |
| Simpson/Basye, Inc. | 1 | 1989-05-11 |
| Ob/Gyn Concepts, Ltd. | 1 | 1987-01-07 |
7 more applicants have KOH clearances. See the full list in Caduvo.
Most recent KOH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K000212 | KARL STORZ Endoscopy-America, Inc. | KSEA CHARDONNES MORCELLATION KNIFE | 2000-04-21 | 88 |
| K921732 | Medikmark, Inc. | MINOR LAP SET | 1994-06-15 | 796 |
| K921730 | Medikmark, Inc. | C-SECTION PACK | 1994-06-15 | 796 |
| K891351 | Simpson/Basye, Inc. | NEWPORT LATERAL VAGINAL RETRACTOR | 1989-05-11 | 62 |
| K892693 | Zinnanti Surgical Instruments, Inc. | VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT | 1989-05-11 | 28 |
Recalls for KOH devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2021-04-15.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code KOH?
KOH is the FDA product code for instrument, manual, general obstetric-gynecologic. It is a Class I device, regulated under 21 CFR 884.4520 and reviewed by the Obstetrics and Gynecology panel.
What device class is KOH?
Class I, regulation 21 CFR 884.4520. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KOH?
Across 15 cleared submissions the average was 159 days from receipt to decision (median 70).
Which companies have the most KOH clearances?
Zinnanti Surgical Instruments, Inc. (3); Medikmark, Inc. (2); KARL STORZ Endoscopy-America, Inc. (1); Simpson/Basye, Inc. (1); Ob/Gyn Concepts, Ltd. (1).
Have KOH devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2021-04-15.
Next steps
- Run an FDA pathway report with predicate devices for product code KOH
- Run a recall and safety report across every KOH manufacturer
- Watch product code KOH 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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