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510(k) K791870

DISPOSABLE SPECIALITY SPONGES by Carwild Corp. — Product Code GDI

K791870 is an FDA 510(k) premarket notification submitted by Carwild Corp. for the device "DISPOSABLE SPECIALITY SPONGES". The FDA issued a decision of Substantially Equivalent on November 5, 1979. The device falls under product code GDI (Dissector, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Carwild Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1979
Date Received
September 21, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dissector, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Carwild Corp.

  • K913303 — LAP SPONGES, MODIFIED (August 6, 1992)
  • K913302 — DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED (July 23, 1992)
  • K833688 — SUTURE REMOVAL KITS STERILE (May 31, 1984)
  • K791872 — LAP SPONGES (November 13, 1979)
  • K791871 — NEUROLOGICAL SPONGES (PATTIES) (November 5, 1979)

Other clearances for product code GDI

  • K896383 — DISPOSABLE EXTERNAL CLAMPS (December 6, 1989)
  • K850288 — HEPATIC PARENCHYMAL SUCTION DISSECTOR (March 18, 1985)
  • K831912 — ROUND-BEEHIVE- DISSECTORS 3/8 (October 31, 1983)
  • K822569 — TYMPANOPLASTY & SKIN DISSECTORS (October 6, 1982)
  • K803292 — FIELD SUCTION DISSECTOR (January 29, 1981)
  • K791703 — TEW BYPASS INSTRUMENTS & DISSECTING KIT (October 4, 1979)

FDA data resources