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510(k) K892820

FORCEPS, SURGICAL, GYNECOLOGICAL by The South India Surgical Co. Pvt. , Ltd. — Product Code HCZ

K892820 is an FDA 510(k) premarket notification submitted by The South India Surgical Co. Pvt. , Ltd. for the device "FORCEPS, SURGICAL, GYNECOLOGICAL". The FDA issued a decision of Substantially Equivalent on June 22, 1989. The device falls under product code HCZ (Forceps, Surgical, Gynecological), a Class II device regulated under 21 CFR 884.4530. The South India Surgical Co. Pvt. , Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1989
Date Received
April 11, 1989
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 The South India Surgical Co. Pvt. , Ltd.

  • K892823 — PLASTER CUTTING SCISSORS (May 25, 1989)

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)
  • K944055 — FORCEPS, SURGICAL GYNECOLOGICAL (September 20, 1994)
  • K941528 — PEARL PACKING FORCEPS (May 12, 1994)
  • K926533 — Z-CLAMP FORCEPS (February 25, 1994)
  • K926484 — CORSON MYOMA GRASPING FORCEPS (February 25, 1994)
  • K926531 — HYSTERECTOMY FORCEPS (February 25, 1994)
  • K930799 — VARIOUS FORCEPS (February 24, 1994)
  • K926528 — OVUM FORCEPS (February 24, 1994)

FDA data resources