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510(k) K760175

DRAPE, TRANSURETHRAL RESECTION (TUR) by V. Mueller O.V. Baxter Healthcare Corp. — Product Code EYX

K760175 is an FDA 510(k) premarket notification submitted by V. Mueller O.V. Baxter Healthcare Corp. for the device "DRAPE, TRANSURETHRAL RESECTION (TUR)". The FDA issued a decision of Substantially Equivalent on August 30, 1976. The device falls under product code EYX (Drape, Pure Latex Sheet, With Self-Retaining Finger Cot), a Class II device regulated under 21 CFR 878.4370. 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
August 30, 1976
Date Received
July 6, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Pure Latex Sheet, With Self-Retaining Finger Cot
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
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)
  • K760273 — LITHOTRITE (December 6, 1976)
  • K760182 — SHEATH, RESECTOSCOPE (December 2, 1976)

FDA data resources