Home / 510(k) Clearances / K770103

510(k) K770103

HOOK, IRIS, SHEPARD U-SHAPED by Edward Weck, Inc. — Product Code HNQ

K770103 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "HOOK, IRIS, SHEPARD U-SHAPED". The FDA issued a decision of Substantially Equivalent on January 25, 1977. The device falls under product code HNQ (Hook, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1977
Date Received
January 17, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hook, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
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 HNQ

  • K030471 — OPHTEC ENCLAVATION NEEDLE (April 17, 2003)
  • K022842 — STEPHENS DISPOSABLE HOOKS (November 1, 2002)
  • K874991 — PRISMA DISPOSABLE IRRIGATING IRIS HOOK (April 13, 1988)
  • K870440 — LOOK LENS LOOPS (February 20, 1987)
  • K864292 — DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY (December 29, 1986)
  • K863988 — THORTON TITANIUM HOOK ANGLED RIGHT (October 31, 1986)
  • K801469 — BONN MICRO IRIS HOOK (NON-STERILE) #7613 (July 28, 1980)
  • K791985 — HOOKS #'S 7600,7602,7603,7616 (October 4, 1979)
  • K770098 — HOOK, IRIS, HERSHMAN (January 24, 1977)

FDA data resources