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510(k) K882422

DISPOSABLE ARACHNOID KNIFE by Microbio-Medics, Inc. — Product Code HAO

K882422 is an FDA 510(k) premarket notification submitted by Microbio-Medics, Inc. for the device "DISPOSABLE ARACHNOID KNIFE". The FDA issued a decision of Substantially Equivalent on September 6, 1988. The device falls under product code HAO (Instrument, Surgical, Non-Powered), a Class I device regulated under 21 CFR 882.4535. Microbio-Medics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1988
Date Received
June 13, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Non-Powered
Device Class
Class I
Regulation Number
882.4535
Review Panel
NE
Submission Type

Other clearances by Microbio-Medics, Inc.

  • K923353 — VENTILATION TUBES W/ HYDROGEL COATING (May 18, 1993)
  • K922572 — 321Q MINIMUM ENERGY TINNITUS SUPPRESSOR (November 2, 1992)
  • K913276 — MICROTEK MEDICAL'S SOUND STIKS (October 21, 1991)
  • K904239 — SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES (June 21, 1991)
  • K910167 — MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM (April 15, 1991)
  • K900726 — MICROTEK MEDICAL'S BLOOD COLLECTION KIT (May 4, 1990)
  • K901154 — MICROTEK'S SURGICAL LAMP HANDLE & COVER (March 20, 1990)
  • K895815 — MICROTEK TOTAL OSSICULAR PROTHESIS (December 26, 1989)
  • K895814 — MICROTEK PISTON & WIRE PROSTHESES (December 26, 1989)
  • K895502 — MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT (December 8, 1989)

Other clearances for product code HAO

  • K220920 — Matreneu Percutaneous Balloon Compression Kit (September 7, 2022)
  • K940973 — MULLAN GANGLION MICROCOMPRESSION SET (September 29, 1995)
  • K951492 — RIB RESECTOR (May 18, 1995)
  • K943115 — AUTO SUTURE PITUITARY SPINAL RONGEUR (July 25, 1994)
  • K942970 — AUTO SUTURE SPINAL ELEVATOR (July 20, 1994)
  • K942969 — AUTO SUTURE SPINAL NERVE HOOK (July 20, 1994)
  • K942968 — AUTO SUTURE SPINAL OSTEOTOME (July 20, 1994)
  • K942971 — AUTO SUTURE SPINAL DISSECTOR (July 20, 1994)
  • K942967 — AUTO SUTURE SPINAL CURETTE (July 20, 1994)
  • K923723 — SILICONE BRAIN SPATULA SET (August 12, 1992)

FDA data resources