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510(k) K760273

LITHOTRITE by V. Mueller O.V. Baxter Healthcare Corp. — Product Code FGK

K760273 is an FDA 510(k) premarket notification submitted by V. Mueller O.V. Baxter Healthcare Corp. for the device "LITHOTRITE". The FDA issued a decision of Substantially Equivalent on December 6, 1976. The device falls under product code FGK (Tripsor, Stone, Bladder), a Class II device regulated under 21 CFR 876.4500. 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
December 6, 1976
Date Received
July 22, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tripsor, Stone, Bladder
Device Class
Class II
Regulation Number
876.4500
Review Panel
GU
Submission Type

Other clearances by V. Mueller O.V. Baxter Healthcare Corp.

  • K803292 — FIELD SUCTION DISSECTOR (January 29, 1981)
  • 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)
  • K760182 — SHEATH, RESECTOSCOPE (December 2, 1976)
  • K760184 — ELEMENT, WORKING (December 2, 1976)

FDA data resources