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510(k) K162751

Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider by Surgical Instrument Services and Savings, Inc. — Product Code NUJ

K162751 is an FDA 510(k) premarket notification submitted by Surgical Instrument Services and Savings, Inc. for the device "Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider". The FDA issued a decision of Substantially Equivalent on May 1, 2017. The device falls under product code NUJ (Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed), a Class II device regulated under 21 CFR 878.4400. Surgical Instrument Services and Savings, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2017
Date Received
September 30, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Other clearances by Surgical Instrument Services and Savings, Inc.

  • K232130 — Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter (December 15, 2023)
  • K152313 — Medline ReNewal Reprocessed Endopath Endoscopic Instruments (January 6, 2016)
  • K150524 — Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Techn (December 16, 2015)

Other clearances for product code NUJ

  • K232511 — Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) (April 29, 2024)
  • K230251 — Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) (March 28, 2023)
  • K220411 — Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) (May 13, 2022)
  • K211203 — Green OR Reprocessed Aquamantys Bipolar Sealer (April 7, 2022)
  • K191073 — Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter (October 22, 2019)
  • K182588 — Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider (October 31, 2018)
  • K180499 — Reprocessed LigaSure Maryland Jaw Sealer/Divider (April 23, 2018)
  • K180451 — Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider (April 20, 2018)
  • K173214 — NES Reprocessed RF Stylet (RFS) (March 27, 2018)
  • K173740 — Reprocessed DePuy Mitek Ablation Wand (March 19, 2018)

FDA data resources