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510(k) K812205

FORCEP by Reznik Instruments — Product Code GEN

K812205 is an FDA 510(k) premarket notification submitted by Reznik Instruments for the device "FORCEP". The FDA issued a decision of Substantially Equivalent on October 26, 1981. The device falls under product code GEN (Forceps, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Reznik Instruments has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1981
Date Received
August 4, 1981
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 Reznik Instruments

  • K812201 — PHOTOGRAPHIC EQUIPMENT (October 19, 1981)
  • K812199 — TROCAR & TROCAR SLEEVES (October 13, 1981)
  • K812204 — UTERINE MANIPULATORS (October 13, 1981)
  • K812206 — LAPAROSCOPE (October 13, 1981)
  • K812203 — ELECTROSURGICAL UNIT (October 13, 1981)
  • K812202 — FIBER OPTIC LIGHT SOURCE (September 29, 1981)
  • K812200 — INSUFFLATOR (September 29, 1981)
  • K812198 — ACCESSORIES(PROBES, SUCTION TUBES, ETC.) (September 11, 1981)

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