Laparoscopic Needle Holder

FDA 510(k) K924196 · Nusurg, Inc.

Substantially Equivalent

510(k) numberK924196

Submission

Device name
Laparoscopic Needle Holder
Applicant
Nusurg, Inc.
Cincinnati, OH, US
Received
August 20, 1992
Decision date
June 25, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FHQ – Holder, Needle, Gastroenterologic
Device class
Class I (low risk)
Regulation
21 CFR 876.4730
Specialty
Gastroenterology, Urology

Other 510(k)s with product code FHQ

510(k)DeviceApplicantDecision
K974327Winged Needle HolderFHQ · Traditional Phx Technologies Corp.01/09/1998SE
K930330Endoscopic Needleholder, ModificationFHQ · Traditional Holmed Corp.06/08/1993SE
K920706Magnetic Point Guard for Surgical NeedlesFHQ · Traditional Retrax05/26/1993SE
K85178025-230 to 25-390 Various Needle HoldersFHQ · Traditional Artiberia06/20/1985SE
K85177925-100,25-220 Various Needle HoldersFHQ · Traditional Artiberia06/20/1985SE
K771859Needle Holder, MicrovascularFHQ · Traditional Edward Weck, Inc.10/04/1977SE

More from Edward Weck, Inc.

510(k)DeviceDecision
K924792Multiple Purpose ForcepsGCJ · Traditional 04/28/1994SE
K930610Talc Dispenser SyringeKYZ · Traditional 11/04/1993SE
K924517Avitene Dispenser SyringeKYZ · Traditional 10/27/1993SE
K924372Laparoscopic Nerve HookGCJ · Traditional 07/30/1993SE

Questions and answers

When was Laparoscopic Needle Holder cleared by the FDA?

Laparoscopic Needle Holder (K924196) received a 510(k) decision of Substantially Equivalent on June 25, 1993, 309 days after the submission was received.

What is the product code of K924196?

The FDA product code is FHQ – Holder, Needle, Gastroenterologic, a Class I (low risk) device regulated under 21 CFR 876.4730.