Home / 510(k) Clearances / K944055

510(k) K944055

FORCEPS, SURGICAL GYNECOLOGICAL by Owens Precision Systems, Inc. — Product Code HCZ

K944055 is an FDA 510(k) premarket notification submitted by Owens Precision Systems, Inc. for the device "FORCEPS, SURGICAL GYNECOLOGICAL". The FDA issued a decision of Substantially Equivalent on September 20, 1994. The device falls under product code HCZ (Forceps, Surgical, Gynecological), a Class II device regulated under 21 CFR 884.4530. Owens Precision Systems, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1994
Date Received
August 19, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Surgical, Gynecological
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Owens Precision Systems, Inc.

  • K924485 — LAPAROSCOPY SET (March 9, 1994)
  • K924224 — OWENS BIOPSY FORCEPS (February 4, 1994)

Other clearances for product code HCZ

  • K172661 — Fetzer Medical Gynecological Forceps (May 8, 2018)
  • K134047 — JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOI (April 11, 2014)
  • K092840 — INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL (December 3, 2009)
  • K941528 — PEARL PACKING FORCEPS (May 12, 1994)
  • K926533 — Z-CLAMP FORCEPS (February 25, 1994)
  • K926531 — HYSTERECTOMY FORCEPS (February 25, 1994)
  • K926484 — CORSON MYOMA GRASPING FORCEPS (February 25, 1994)
  • K926528 — OVUM FORCEPS (February 24, 1994)
  • K930799 — VARIOUS FORCEPS (February 24, 1994)
  • K930039 — FORCEPS: MCGRAVEY, MCINDOE, GILLIS (February 24, 1994)

FDA data resources