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510(k) K853678

KAMBIN SPINAL INSTRUMENT SET by Pilling Co. — Product Code HTZ

K853678 is an FDA 510(k) premarket notification submitted by Pilling Co. for the device "KAMBIN SPINAL INSTRUMENT SET". The FDA issued a decision of Substantially Equivalent on September 24, 1985. The device falls under product code HTZ (Instrument, Cutting, Orthopedic), a Class I device regulated under 21 CFR 878.4800. Pilling Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1985
Date Received
September 3, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Cutting, Orthopedic
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Pilling Co.

  • K002582 — PILLING E-FRAZIER BIPOLAR SUCTION TUBE (November 3, 2000)
  • K934427 — PILLING LAPAROSCOPIC INSTRUMENTATION (January 10, 1994)
  • K925370 — TRIANGULAR JAW MICROLARYNGEAL FORCEPS (March 18, 1993)
  • K925198 — KAISER NO CANNULA THORACOSCOPY/LAPAROSCOPY INSTR (February 12, 1993)
  • K922971 — NO-SCALPEL VASCETOMY INSTRUMENTS (September 23, 1992)
  • K914015 — CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP (November 21, 1991)
  • K911099 — MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE (June 25, 1991)
  • K911100 — MEHIGAN-PILLING PHLEBETOME TM (June 21, 1991)
  • K904507 — PILLING BRUSH VALVULOTOME (March 1, 1991)
  • K884946 — JEHLE CORONARY PERFUSION CATHETERS (February 6, 1989)

Other clearances for product code HTZ

  • K933933 — CEBOPLANE (April 15, 1994)
  • K931737 — HEDLEYL INTRAMEDULLARY PREPARATION BRUSH (January 7, 1994)
  • K870882 — 45 DEGREE SHAVER (March 23, 1987)
  • K850527 — ARTHROSCOPY SUCTION BIOPSY PUNCH (March 14, 1985)
  • K850423 — CONCEPT SUCTION SLEEVE (March 14, 1985)
  • K841980 — SIDE CUTTING SERRATED BLADE (August 15, 1984)
  • K842774 — CODMAN SUCTION PUNCH-PRODUCT CODES (July 27, 1984)
  • K841974 — RETROGRADE KNIFE 4MM & 5MM (June 19, 1984)
  • K841978 — LATERAL RELEASE KNIFE 5MM & 7MM (June 19, 1984)
  • K841973 — BANANA KNIFE SERRATED (June 19, 1984)

FDA data resources