Minor Lap Set
FDA 510(k) K921732 · Medikmark, Inc.
510(k) numberK921732
Submission
- Device name
- Minor Lap Set
- Applicant
- Medikmark, Inc.
Chicago, IL, US - Received
- April 10, 1992
- Decision date
- June 15, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KOH – Instrument, Manual, General Obstetric-Gynecologic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.4520
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code KOH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K000212 | Ksea Chardonnes Morcellation KnifeKOH · Traditional | KARL STORZ Endoscopy-America, Inc. | 04/21/2000SE |
| K921730 | C-Section PackKOH · Traditional | Medikmark, Inc. | 06/15/1994SE |
| K892693 | Vaginal Specula: Cusco, Guttman, InfantKOH · Traditional | Zinnanti Surgical Instruments, Inc. | 05/11/1989SE |
| K891351 | Newport Lateral Vaginal RetractorKOH · Traditional | Simpson/Basye, Inc. | 05/11/1989SE |
| K891035 | Needle ExtensionsKOH · Traditional | Zinnanti Surgical Instruments, Inc. | 03/22/1989SE |
| K891049 | Zeppelin ScissorsKOH · Traditional | Zinnanti Surgical Instruments, Inc. | 03/17/1989SE |
| K863610 | The Ob-Gyn Concepts Vaginal AspiratorKOH · Traditional | Ob/Gyn Concepts, Ltd. | 01/07/1987SE |
| K840308 | Cat. 4-OBSTETRICS Gynecology Dev'sKOH · Traditional | Imm Enterprises , Ltd. | 03/05/1984SE |
| K823792 | Quartz Retractor/ProbeKOH · Traditional | American V. Mueller | 01/18/1983SE |
| K812204 | Uterine ManipulatorsKOH · Traditional | Reznik Instruments | 10/13/1981SE |
More from Reznik Instruments
| 510(k) | Device | Decision |
|---|---|---|
| K953474 | IV Start KitFPA · Traditional | 10/02/1995SE |
| K923960 | Upper Extermity Drape KitKKX · Traditional | 10/07/1994SE |
| K921733 | Tracheostomy Care TrayJOH · Traditional | 06/15/1994SESK |
| K921730 | C-Section PackKOH · Traditional | 06/15/1994SE |
| K920341 | Laceration TraysKKX · Traditional | 04/23/1992SEKD |
| K920340 | Suture Removal KitKKX · Traditional | 04/23/1992SEKD |
| K920339 | Dressing Change TrayFRG · Traditional | 04/23/1992SEKD |
Questions and answers
When was Minor Lap Set cleared by the FDA?
Minor Lap Set (K921732) received a 510(k) decision of Substantially Equivalent on June 15, 1994, 796 days after the submission was received.
What is the product code of K921732?
The FDA product code is KOH – Instrument, Manual, General Obstetric-Gynecologic, a Class I (low risk) device regulated under 21 CFR 884.4520.