Lowman Bone Forcep

FDA 510(k) K771192 · Edward Weck, Inc.

Substantially Equivalent

510(k) numberK771192

Submission

Device name
Lowman Bone Forcep
Applicant
Edward Weck, Inc.
Mchenry, IL, US
Received
July 1, 1977
Decision date
July 11, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HTD – Forceps
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

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K974594Semkin Bipolar ForcepHTD · Traditional Titan Mfg., Inc.06/24/1998SE
K974593Semkin Insulated Bipolar ForcepHTD · Traditional Titan Mfg., Inc.06/24/1998SE
K913964Marlow/Reddick Laparoscopic Grasping ForcepsHTD · Traditional Marlo Surgical Technology10/23/1991SE
K911180Claw (5MM/10MM) Atraumatic Grasp/Micro ForcepsHTD · Traditional Northgate Technologies, Inc.03/29/1991SE
K895212Tik ExtraktorHTD · Traditional Instruments of Sweden, Inc.09/27/1989SE
K890373Hemorrhoidal ForcepsHTD · Traditional Kinetic Medical Products02/03/1989SE
K890369Gall Stone ForcepsHTD · Traditional Kinetic Medical Products02/03/1989SE
K890263Cilia ForcepsHTD · Traditional Kinetic Medical Products01/27/1989SE

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K914470Pneumo-Seal(Tm)GCJ · Traditional 11/29/1991SE
K911272Endoscopic Needlholder Cat. Number 114705FHG · Traditional 07/02/1991SE
K902108Hem-O-Lok(Tm)FZP · Traditional 08/06/1990SE
K902232Weck Electrosurgical Generator #174200GEI · Traditional 08/02/1990SE
K897045Bowie-Dick Test Card Catalog Number 008018JOJ · Traditional 02/15/1990SE
K871110Coronary Artery Bypass Graft (Cabg) MarkerDSY · Traditional 08/27/1987SE
K851251Auto/Manual Titanium Hemoclip Ligating Clip 527200FZP · Traditional 07/02/1985SE

Questions and answers

When was Lowman Bone Forcep cleared by the FDA?

Lowman Bone Forcep (K771192) received a 510(k) decision of Substantially Equivalent on July 11, 1977, 10 days after the submission was received.

What is the product code of K771192?

The FDA product code is HTD – Forceps, a Class I (low risk) device regulated under 21 CFR 878.4800.