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510(k) K884181

MANUAL SURGICAL INSTRUMENTS (SEVERAL MODELS) by Sales & Marketing Assoc. — Product Code GEN

K884181 is an FDA 510(k) premarket notification submitted by Sales & Marketing Assoc. for the device "MANUAL SURGICAL INSTRUMENTS (SEVERAL MODELS)". The FDA issued a decision of Substantially Equivalent on November 10, 1988. The device falls under product code GEN (Forceps, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1988
Date Received
October 3, 1988
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 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)
  • K900948 — GS-1002 GRASPING FORCEP, 5MM WITH RATCHET (April 18, 1990)
  • K900952 — GS-1200 GRASPING/EXTRACTING FORCEP, 10MM (April 18, 1990)
  • K900951 — GS-7000 CLIP-APPLYING FORCEP, 10MM, MEDIUM CLIP (April 18, 1990)
  • K900960 — GS-1500 CLAW FORCEP, 10MM (April 18, 1990)
  • K891896 — TISSUE FORCEPS, VARIOUS TYPES (April 12, 1989)

FDA data resources