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510(k) K883963

RANEY AND LEROY-RANEY SCALP CLIP by New England Surgical Instrument Corp. — Product Code HBO

K883963 is an FDA 510(k) premarket notification submitted by New England Surgical Instrument Corp. for the device "RANEY AND LEROY-RANEY SCALP CLIP". The FDA issued a decision of Substantially Equivalent on October 7, 1988. The device falls under product code HBO (Clip, Scalp), a Class II device regulated under 21 CFR 882.4150. New England Surgical Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1988
Date Received
September 20, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Scalp
Device Class
Class II
Regulation Number
882.4150
Review Panel
NE
Submission Type

Other clearances by New England Surgical Instrument Corp.

  • K895331 — ELECTROSURGICAL ELECTRODE (September 15, 1989)
  • K895337 — ELECTROSURGICAL COAGULATION SUCTION TUBE (September 15, 1989)
  • K883396 — HANDSWITCHING MONOPOLAR PENCIL (September 13, 1988)
  • K880863 — BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-1200 (April 19, 1988)
  • K880859 — SURGICAL BURS (March 21, 1988)
  • K872271 — VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPS (June 26, 1987)
  • K872209 — ARTHROPLASTY MALLET (June 23, 1987)
  • K864770 — SUCTION TUBE (February 24, 1987)
  • K864775 — CHISEL (OSTEOTOME, GOUGE, ETC.) (February 12, 1987)
  • K864771 — CHUCK HANDLE (February 4, 1987)

Other clearances for product code HBO

  • K050044 — MEDTRONIC CLIP GUN KIT (February 7, 2005)
  • K033660 — STORZ RANEY SCALP CLIP, MODEL 1-20-004-05 (January 7, 2004)
  • K012219 — SCALPFIX CLIP SYSTEM (July 31, 2001)
  • K944311 — ACRA-CUT (November 18, 1994)
  • K905433 — CODMAN DISPOSABLE SCALP CLIP APPLIER (February 21, 1991)
  • K896723 — CLIP GUN WITH RANEY TYPE SCALP CLIPS (March 23, 1990)
  • K894778 — CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER (December 6, 1989)
  • K890443 — CASPAR SCALP CLIP, APPLIER (June 15, 1989)
  • K881265 — RANEY CLIPS (May 31, 1988)

FDA data resources