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510(k) K971968

SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97) by Remington Medical, Inc. — Product Code DSA

K971968 is an FDA 510(k) premarket notification submitted by Remington Medical, Inc. for the device "SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97)". The FDA issued a decision of Substantially Equivalent on July 23, 1997. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. Remington Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1997
Date Received
May 28, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Device Class
Class II
Regulation Number
870.2900
Review Panel
CV
Submission Type

Other clearances by Remington Medical, Inc.

  • K251904 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speake (November 20, 2025)
  • K241583 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charge (August 30, 2024)
  • K211589 — VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charge (January 27, 2022)
  • K212065 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charge (October 7, 2021)
  • K191315 — Remington Medical, Inc. Automatic Cutting Needle (NAC) (July 12, 2019)
  • K150266 — Remington Medical Inc. Tuohy Epidural Needles (June 4, 2015)
  • K130282 — REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT (May 13, 2013)
  • K050884 — ADAPTER CABLE (May 19, 2005)
  • K040266 — CORE NEEDLE BIOPSY (July 9, 2004)
  • K990428 — DRAINAGE BAG (August 12, 1999)

Other clearances for product code DSA

  • K254114 — Baylis Connector Cable (January 18, 2026)
  • K252827 — IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abb (December 1, 2025)
  • K251669 — IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, (September 30, 2025)
  • K242986 — SpO2 Extension Cable (May 2, 2025)
  • K243545 — Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 98980 (January 17, 2025)
  • K240087 — RT Carbon ECG Leads (September 13, 2024)
  • K240377 — LIFEPAK® ECG Cables (May 7, 2024)
  • K240156 — LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack (April 30, 2024)
  • K222712 — Fogg System Patient Monitoring Cables (November 22, 2023)
  • K230571 — RFP-100A Connector Cable (Single Use) (May 30, 2023)

FDA data resources