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510(k) K953962

FORCEPS by Biopsys Medical, Inc. — Product Code GEN

K953962 is an FDA 510(k) premarket notification submitted by Biopsys Medical, Inc. for the device "FORCEPS". The FDA issued a decision of Substantially Equivalent on September 8, 1995. The device falls under product code GEN (Forceps, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Biopsys Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1995
Date Received
August 22, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Biopsys Medical, Inc.

  • K970817 — MICROMARK CLIP (September 11, 1997)
  • K970565 — MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME) (March 28, 1997)
  • K963015 — SURGICAL STAPLE MARKER DEVICE (MODIFY) (October 7, 1996)
  • K960019 — RETRACTOR ARM CLAMP (February 9, 1996)
  • K953880 — BIOPSY NEEDLE (September 8, 1995)
  • K951326 — BIOPSY DEVICE ACCESSORY (May 15, 1995)
  • K951229 — MODIFIED BIOPSY NEEDLE (April 6, 1995)
  • K950006 — SURGICAL STAPLE MARKER (March 15, 1995)
  • K943863 — NEEDLE GUIDE (December 29, 1994)
  • K945573 — BIOPSY DEVICE ACCESSORY (December 9, 1994)

Other clearances for product code GEN

  • K031828 — NATURALASE LP ND:YAG LASER (July 17, 2003)
  • K932385 — SUTURE REMOVING FORCEPS (August 6, 1993)
  • K904723 — FORCEPS (July 26, 1991)
  • K911159 — PALPATION PROBE (March 29, 1991)
  • K900948 — GS-1002 GRASPING FORCEP, 5MM WITH RATCHET (April 18, 1990)
  • K900952 — GS-1200 GRASPING/EXTRACTING FORCEP, 10MM (April 18, 1990)
  • K900960 — GS-1500 CLAW FORCEP, 10MM (April 18, 1990)
  • K900951 — GS-7000 CLIP-APPLYING FORCEP, 10MM, MEDIUM CLIP (April 18, 1990)
  • K891896 — TISSUE FORCEPS, VARIOUS TYPES (April 12, 1989)
  • K891401 — HEMOSTATIC FORCEPS BRUNS.,GEMINI,SPENCER-WELL,KANT (April 6, 1989)

FDA data resources