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510(k) K803292

FIELD SUCTION DISSECTOR by V. Mueller O.V. Baxter Healthcare Corp. — Product Code GDI

K803292 is an FDA 510(k) premarket notification submitted by V. Mueller O.V. Baxter Healthcare Corp. for the device "FIELD SUCTION DISSECTOR". The FDA issued a decision of Substantially Equivalent on January 29, 1981. The device falls under product code GDI (Dissector, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. V. Mueller O.V. Baxter Healthcare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1981
Date Received
December 30, 1980
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 V. Mueller O.V. Baxter Healthcare Corp.

  • K792383 — KELMAN DIPSTICK (December 11, 1979)
  • K771197 — NORTON ENDOTRACHEAL (August 16, 1977)
  • K771302 — PFISTER-SCHWARTZ STONE RETRIEVER (August 2, 1977)
  • K770959 — BOUGIE, FILIFORM, JACKSON (June 14, 1977)
  • K770280 — CORD, ELECTROSURGICAL-STERILE & DISPOS. (April 15, 1977)
  • K760851 — CONVERSE ALTAR RETRACTOR (March 10, 1977)
  • K761242 — TEFLON COATED RESECTOSCOPE SHEATH (December 16, 1976)
  • K760273 — LITHOTRITE (December 6, 1976)
  • K760182 — SHEATH, RESECTOSCOPE (December 2, 1976)
  • K760184 — ELEMENT, WORKING (December 2, 1976)

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)
  • K791870 — DISPOSABLE SPECIALITY SPONGES (November 5, 1979)
  • K791703 — TEW BYPASS INSTRUMENTS & DISSECTING KIT (October 4, 1979)

FDA data resources