Atlas FDA

HDC

20 FDA 510(k) clearances · Product code

46 daysmedian time to decision
260 days90th percentile
20clearances measured

FDA profile

Official device name
Tenaculum, Uterine
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4530
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
1999: 1 · 2000: 2 · 2001: 1 · 2002: 1 · 2006: 8 · 2009: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Carevix™ Suction Cervical Stabilizer (K223866)Aspivix SA2023-01-25
ASPIVIX v1.1 Cervical Suction Tenaculum (K203820)Aspivix SA2021-08-17
Bioceptive Suction Cervical Retractor (K142204)Bioceptive, Inc.2014-12-19
JARIT HULKA UTERINE TENACULUM FORCEPS (K082349)J. Jamner Surgical Instruments, Inc.2008-11-21
GYN DISPOSABLES TENACULUM 356T (K073182)Gyn-Disposables, Inc.2007-11-28
FEMTEN CERVICAL TENACULUM (K062563)Fem Suite, LLC2007-05-18
BURBANK TENACULUM (K060573)Vascular Control Systems, Inc.2006-04-21
TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM (K032585)Ron-Tech Medical , Ltd.2004-01-09
BURBANK TENACULUM, MODEL 09-0011-01 (K030078)Vascular Control Systems, Inc.2003-01-24
UTERINE TENACLUM HOOK (K001818)Towne Brothers (Pvt.), Ltd.2000-08-30
TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE (K992071)Ron-Tech Medical , Ltd.1999-08-27
GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM (K980247)Gynex Corp.1998-03-17
ATRAUMATIC TENACULA (K930037)Thomasville Medical Assoc.1994-02-24
OTT CERVICAL TENACULUM (K910287)Marlo Surgical Technology1991-02-28
IRRIGATOR STAND (K894891)Commercial Products & Engineering Co.1989-08-23
CAMPION CERVICAL HOOK (K891349)Simpson/Basye, Inc.1989-03-29
NEWPORT CERVICAL MANIPULATOR (K891350)Simpson/Basye, Inc.1989-03-29
REID ENDOCERVICAL SPREADER (K891347)Simpson/Basye, Inc.1989-03-29
ATRAUMATIC TENACULA (K891033)Zinnanti Surgical Instruments, Inc.1989-03-17
UTERINE TENTACULUM (K890379)Kinetic Medical Products1989-02-13

Track HDC automatically

Every clearance here is in the API, with alerts when new ones post.