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510(k) K800162

ONCE TM by G.D. Searle and Co. — Product Code HDW

K800162 is an FDA 510(k) premarket notification submitted by G.D. Searle and Co. for the device "ONCE TM". The FDA issued a decision of Substantially Equivalent on February 11, 1980. The device falls under product code HDW (Diaphragm, Contraceptive (And Accessories)), a Class II device regulated under 21 CFR 884.5350. G.D. Searle and Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1980
Date Received
January 25, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diaphragm, Contraceptive (And Accessories)
Device Class
Class II
Regulation Number
884.5350
Review Panel
OB
Submission Type

Other clearances by G.D. Searle and Co.

  • K821159 — IN-LINE OXYGEN MONITORING SYSTEM (May 25, 1982)
  • K811068 — BYPASS COIL (May 27, 1981)
  • K811071 — VENOUS OXYGEN PROBE (May 5, 1981)
  • K803238 — INTRAVASCULAR CATHETER (April 23, 1981)
  • K810630 — SILICONE ELASTOMER COATED LATEX FOLEY (March 31, 1981)
  • K810131 — ADMINISTRATION SET (February 26, 1981)
  • K802485 — SEARLE VASCULAR LOOPS (February 12, 1981)
  • K801805 — METRONIDAZOLE DISCS (February 10, 1981)
  • K810112 — SWR DISPOSABLE PREP RAZOR (February 4, 1981)
  • K802213 — WHITE KNIGHT BOVIE CORD/SUCTION TUBE (October 10, 1980)

Other clearances for product code HDW

  • K140305 — CAYA CONTOURED DIAPHRAGM (August 26, 2014)
  • K080040 — ORTHO ALL-FLEX DIAPHRAGM (August 25, 2008)
  • K063223 — MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL (January 23, 2008)

FDA data resources