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510(k) K760850

PARKES HUMP GAUGE STRAIGHT 7 (18 CM) by V. Mueller O.V. Baxter Healthcare Corp. — Product Code GDH

K760850 is an FDA 510(k) premarket notification submitted by V. Mueller O.V. Baxter Healthcare Corp. for the device "PARKES HUMP GAUGE STRAIGHT 7 (18 CM)". The FDA issued a decision of Substantially Equivalent on November 3, 1976. The device falls under product code GDH (Gouge, 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
November 3, 1976
Date Received
October 15, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gouge, 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.

  • 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)

Other clearances for product code GDH

  • K903419 — MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE (August 9, 1990)
  • K900487 — MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVE (February 9, 1990)
  • K891901 — GOUGES, ALEXANDER, BISHOP, LUCAS (April 12, 1989)
  • K874879 — AUTO SUTURE(R) SURGIPORT DISPOS SURG TROCAR/SLEEVE (December 17, 1987)
  • K842822 — CHERMEL BONE GOUGES (August 2, 1984)

FDA data resources