Ott Cervical Tenaculum
by Marlo Surgical Technology 510(k)
Active
510(k) K910287
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK910287 | Date28 Feb 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HDC
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.4530
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Ott Cervical Tenaculum is a Tenaculum, Uterine, a type of medical device used in Obstetrics/Gynecology. It is classified as a device class 2. The device is used to perform its intended function in the field of Obstetrics/Gynecology.
The Ott Cervical Tenaculum is supplied with a product code of HDC and is regulated under regulation number 884.4530. It has been assigned a K number of K910287 and has received FDA 510K clearance. The device is substantially equivalent and has a decision code of SESE. It is used in the medical specialty of Obstetrics/Gynecology.
Other devices from Marlo Surgical Technology
Questions
AI-generated answers, 1 Oct 2026
What is the Ott Cervical Tenaculum used for?
The Ott Cervical Tenaculum is used in the medical specialty of Obstetrics/Gynecology to perform its intended function, specifically as a Tenaculum, Uterine.
Is the Ott Cervical Tenaculum supplied sterile?
The device data does not specify if the Ott Cervical Tenaculum is supplied sterile, but it is classified as a device class 2 and has received FDA 510K clearance.
What is the product code for the Ott Cervical Tenaculum?
The Ott Cervical Tenaculum has a product code of HDC and is regulated under regulation number 884.4530.