# K082349: Jarit Hulka Uterine Tenaculum Forceps

- Pathway: 510(k) (Traditional)
- Applicant: J. Jamner Surgical Instruments, Inc.
- Decided: Nov 21, 2008 after 98 days
- Product code: HDC (Tenaculum, Uterine)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) JARIT Braun Uterine Tenaculum Forceps: named in the summary without a submission number
- (no number) Hulka Tenaculum: named in the summary without a submission number

## Recalls of this device
- Mar 3, 2014 · Class II · Z-1305-2014: Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during

## Indications for use
JARIT ® Hulka Uterine Tenaculum Forceps are indicated to stabilize the cervix and manipulate the uterine fundus under direct pelviscopic visualization in women whose uteri are anteverted or retroverted.

Source page: https://510kreport.com/device/K082349
Methodology: https://510kreport.com/methodology