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510(k) K800721

GENERAL UTILITY SURG. SCISSORS #460180- by Edward Weck, Inc. — Product Code HRR

K800721 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "GENERAL UTILITY SURG. SCISSORS #460180-". The FDA issued a decision of Substantially Equivalent on May 8, 1980. The device falls under product code HRR (Scissors, Orthopedic, Surgical), a Class I device regulated under 21 CFR 888.4540. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1980
Date Received
April 1, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scissors, Orthopedic, Surgical
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Edward Weck, Inc.

  • K915378 — WECK TROCAR (June 29, 1992)
  • K914690 — LM15(TM), CATALOG NUMBER - 523821 (March 23, 1992)
  • K911915 — HEMOCLIP II (January 9, 1992)
  • K914470 — PNEUMO-SEAL(TM) (November 29, 1991)
  • K911272 — ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705 (July 2, 1991)
  • K902108 — HEM-O-LOK(TM) (August 6, 1990)
  • K902232 — WECK ELECTROSURGICAL GENERATOR #174200 (August 2, 1990)
  • K897045 — BOWIE-DICK TEST CARD CATALOG NUMBER 008018 (February 15, 1990)
  • K871110 — CORONARY ARTERY BYPASS GRAFT (CABG) MARKER (August 27, 1987)
  • K851251 — AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200 (July 2, 1985)

Other clearances for product code HRR

  • K890212 — MICROSURGICAL SCISSORS (January 27, 1989)
  • K890261 — TRIGEMINAL SCISSORS (January 27, 1989)
  • K890225 — SURGICAL SCISSORS (January 27, 1989)
  • K873502 — SCISSOR, RIGHT (November 2, 1987)
  • K873501 — SCISSOR, LEFT (November 2, 1987)
  • K851800 — 69-100 TO 69-114 VARIOUS CUTICLE SCISSORS (June 20, 1985)
  • K842953 — ALL-HANDS MEDICAL SUPPLY SUTURE REMOVAL (August 21, 1984)

FDA data resources