Home / 510(k) Clearances / K883582

510(k) K883582

VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM by Surgidyne, Inc. — Product Code BTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1988
Date Received
August 22, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

Other clearances by Surgidyne, Inc.

  • K892334 — LEONARD TUBE (May 31, 1989)
  • K864822 — VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS (January 15, 1987)
  • 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 BTA

  • K251450 — Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (June 6, 2025)
  • K244033 — Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA61 (May 16, 2025)
  • K251101 — AIRO Suction Unit (AIRO-01) (April 26, 2025)
  • K250697 — Electric Nasal Aspirator (BC026, BC025, BC023) (April 23, 2025)
  • K241799 — ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose sys (March 7, 2025)
  • K243138 — Geon (S2) Nasal Aspirator (February 4, 2025)
  • K241852 — Nasal Aspirator (NS 13) (December 31, 2024)
  • K242028 — Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) (November 19, 2024)
  • K241202 — Electric nasal aspirator (HTD2601US) (July 1, 2024)
  • K233901 — Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009 (March 20, 2024)