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510(k) K844062

FORCEPS & HAMOSTATS by I M, Inc. — Product Code GEN

K844062 is an FDA 510(k) premarket notification submitted by I M, Inc. for the device "FORCEPS & HAMOSTATS". The FDA issued a decision of Substantially Equivalent on January 18, 1985. The device falls under product code GEN (Forceps, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. I M, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1985
Date Received
October 18, 1984
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 I M, Inc.

  • K914600 — NEUROLOGICAL SPONGE (December 30, 1992)
  • K892389 — BIOPSY KIT (July 17, 1989)
  • K881363 — SYRINGE PREFILLED WITH WATER (June 23, 1988)
  • K880753 — UMBILICAL CORD CLAMP (April 27, 1988)
  • K872741 — NUTRIPUMP (October 20, 1987)
  • K871495 — BANDAGES CATALOG NUMBER: 101 TO 220 (May 8, 1987)
  • K863785 — MAKLER CATHETER (December 11, 1986)
  • K854155 — STERILE SALINE SOLUTION (December 10, 1985)
  • K853287 — HUBOUT (October 17, 1985)
  • K853288 — FEEDING UNITS & TUBES (October 4, 1985)

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)
  • K900960 — GS-1500 CLAW FORCEP, 10MM (April 18, 1990)
  • K900948 — GS-1002 GRASPING FORCEP, 5MM WITH RATCHET (April 18, 1990)
  • K900952 — GS-1200 GRASPING/EXTRACTING FORCEP, 10MM (April 18, 1990)
  • K891896 — TISSUE FORCEPS, VARIOUS TYPES (April 12, 1989)

FDA data resources