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510(k) K852711

SCALPEL HANDLE #3 SS 410 OR 420 by The Huxley Instrument Corp. — Product Code GDZ

K852711 is an FDA 510(k) premarket notification submitted by The Huxley Instrument Corp. for the device "SCALPEL HANDLE #3 SS 410 OR 420". The FDA issued a decision of Substantially Equivalent on July 15, 1985. The device falls under product code GDZ (Handle, Scalpel), a Class I device regulated under 21 CFR 878.4800. The Huxley Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1985
Date Received
June 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handle, Scalpel
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by The Huxley Instrument Corp.

  • K852721 — BOZEMAN UTERINE FORCEPS, STRAIGHT, 10+410 0R 420 (September 6, 1985)
  • K853016 — STILLE ANGULAR RONGEUR, 8-3/4 SS 410 (August 7, 1985)
  • K852993 — BONE RONGEURS (August 7, 1985)
  • K853015 — SELF-CENTERING BONE HOLDING FORCEPS, 10-1/4 SS420 (July 29, 1985)
  • K852716 — TAYLOR PERCUSSION HAMMER SS 410 OR 420 (July 26, 1985)
  • K852734 — O.R. SCISSORS, STRAIGHT, 5-1/2+SHP/SHP SS (July 15, 1985)
  • K852713 — RUSSIAN TISSUE FORCEPS, 6 + SS 410 OR 420 (July 15, 1985)
  • K852719 — MAYO HEGAR NEEDLE HOLDER, G+SS 410 OR 420 (July 15, 1985)
  • K852720 — THUMB DRESSING FORCEPS, 5+SS 410 OR 420 (July 15, 1985)
  • K852730 — CRILE FORCEPS, STRIAGHT, 6-1/4+SS 410 OR 420 (July 15, 1985)

Other clearances for product code GDZ

  • K091462 — SPECTRA MEDICAL SAFETY SCAPEL (December 15, 2009)
  • K890242 — SCALPEL HANDLE (January 27, 1989)
  • K884512 — BEAVER(R) HANDLE (November 17, 1988)
  • K863951 — P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE (October 24, 1986)
  • K863808 — THE S. CORDERO STYLUS (October 14, 1986)
  • K863212 — KEISEI HANDLES FOR SURGICAL BLADES (September 2, 1986)
  • K854858 — SCALPEL HANDLE (December 24, 1985)
  • K852735 — SCALPEL HANDLE #7 SS 410 OR 420 (July 15, 1985)
  • K851750 — 7-103, 7-104, 7-107 SCALPEL HANDLES, #3 #4 #7 (June 20, 1985)
  • K852042 — BRIMFIELD CANNULATED BLADE HOLDER (June 11, 1985)

FDA data resources