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510(k) K801075

STRAITH CHISEL FORCEPS by Surgical Technology Laboratories, Inc. — Product Code GEN

K801075 is an FDA 510(k) premarket notification submitted by Surgical Technology Laboratories, Inc. for the device "STRAITH CHISEL FORCEPS". The FDA issued a decision of Substantially Equivalent on May 20, 1980. The device falls under product code GEN (Forceps, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Surgical Technology Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1980
Date Received
May 6, 1980
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 Surgical Technology Laboratories, Inc.

  • K170582 — Saf-T-Vac Smoke and Fluid Evacuator (April 14, 2017)
  • K021889 — SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) (October 16, 2002)
  • K983756 — SURGIFORM ANATOMICAL MALAR (November 20, 1998)
  • K983755 — NASAL DORSAL SERIES (November 20, 1998)
  • K983754 — STANDARD CHIN (November 20, 1998)
  • K964443 — SURGIFORM ANATOMICAL MALAR (December 20, 1996)
  • K840835 — STRAITH DRAIN INSERTER (April 23, 1984)
  • K831078 — STRAITH ORAL AIRWAY (June 24, 1983)
  • K801074 — STRAITH NASAL IMPLANT (June 17, 1980)
  • K801072 — STRAITH NASAL SPLINT (June 17, 1980)

Other clearances for product code GEN

  • K031828 — NATURALASE LP ND:YAG LASER (July 17, 2003)
  • K953962 — FORCEPS (September 8, 1995)
  • K932385 — SUTURE REMOVING FORCEPS (August 6, 1993)
  • K904723 — FORCEPS (July 26, 1991)
  • K911159 — PALPATION PROBE (March 29, 1991)
  • K900951 — GS-7000 CLIP-APPLYING FORCEP, 10MM, MEDIUM CLIP (April 18, 1990)
  • K900948 — GS-1002 GRASPING FORCEP, 5MM WITH RATCHET (April 18, 1990)
  • K900960 — GS-1500 CLAW FORCEP, 10MM (April 18, 1990)
  • K900952 — GS-1200 GRASPING/EXTRACTING FORCEP, 10MM (April 18, 1990)
  • K891896 — TISSUE FORCEPS, VARIOUS TYPES (April 12, 1989)

FDA data resources