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510(k) K790467

SURGICAL EYE SPONGE by Medtech Intl., Inc. — Product Code EFQ

K790467 is an FDA 510(k) premarket notification submitted by Medtech Intl., Inc. for the device "SURGICAL EYE SPONGE". The FDA issued a decision of Substantially Equivalent on March 26, 1979. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Medtech Intl., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1979
Date Received
March 5, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze/Sponge, Internal
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Medtech Intl., Inc.

  • K920876 — CUT RESISTANT GLOVES OR SURGICAL GLOVE LINER (December 11, 1992)
  • K853843 — IV MATE (January 9, 1986)
  • K791462 — HYPERDERMIC NEEDLE WITH SENSOR #514 (September 24, 1979)
  • K790389 — GAUZE & COTTON SPONGES (March 26, 1979)
  • K781157 — STIMULATOR, NERVE, TRANSCUTANEOUS (September 20, 1978)

Other clearances for product code EFQ

  • K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE (August 12, 1999)
  • K991215 — SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S (June 11, 1999)
  • K990974 — VITOP DRESSING (June 9, 1999)
  • K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE (April 23, 1999)
  • K984187 — CROSSTEX NON-WOVEN SPONGES (February 18, 1999)
  • K983016 — GAUZE, SPONGES, CAT # 11-003 (February 12, 1999)
  • K983348 — DYNAREX TRACHEOSTOMY SPONGE (December 11, 1998)
  • K983450 — STARRYSHINE GAUZE SPONGE (November 12, 1998)
  • K982648 — JOAN II (September 30, 1998)
  • K980791 — DUMEX PAK-ITS WOVEN RIBBON PACKING (April 29, 1998)

FDA data resources