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510(k) K864822

VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS by Surgidyne, Inc. — Product Code BTC

K864822 is an FDA 510(k) premarket notification submitted by Surgidyne, Inc. for the device "VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS". The FDA issued a decision of Substantially Equivalent on January 15, 1987. The device falls under product code BTC (Bag, Reservoir), a Class I device regulated under 21 CFR 868.5320. Surgidyne, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1987
Date Received
December 9, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Reservoir
Device Class
Class I
Regulation Number
868.5320
Review Panel
AN
Submission Type

Other clearances by Surgidyne, Inc.

  • K892334 — LEONARD TUBE (May 31, 1989)
  • K883582 — VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM (October 3, 1988)
  • K860030 — SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID (February 12, 1986)
  • K852180 — SURGIDYNES VARIDYNE 350-2I & 350-2C CORDLESS ELEC. (July 1, 1985)
  • K850634 — SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS (June 28, 1985)

Other clearances for product code BTC

  • K181424 — PeDIA (September 25, 2018)
  • K940220 — REBREATHER BAGS (May 27, 1994)
  • K932584 — BREATHING BAGS (July 16, 1993)
  • K932581 — BREATHING BAGS (July 16, 1993)
  • K932496 — PRECISION MED PRODUCTS, LTD. BREATHING BAGS (July 16, 1993)
  • K932191 — BREATHING BAGS (July 2, 1993)
  • K894906 — ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER (September 18, 1989)
  • K880680 — KING SYSTEMS, BREATHING BAG (March 3, 1988)
  • K841411 — ROLLED NECK W/PLUG (April 18, 1984)
  • K841412 — ROLLED NECK W/TAP (April 18, 1984)

FDA data resources