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510(k) K060170

ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS by Erbe USA, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2006
Date Received
January 23, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Erbe USA, Inc.

  • K221177 — Erbe's Tubing/Cap Sets (August 11, 2022)
  • K191438 — ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector (June 27, 2019)
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  • K182444 — ERBEFLO Olympus Scope Port Connector (November 6, 2018)
  • K162152 — Erbe’s CO2 Tubing/Cap Sets (August 31, 2016)
  • K143306 — ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe (October 27, 2015)
  • K151041 — ERBECRYO 2 Cryosurgical Unit with accessories (May 4, 2015)
  • K143186 — Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope P (December 18, 2014)
  • K132340 — ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYB (December 17, 2013)
  • K133180 — ERBE ESU MODEL VIO DV WITH ACCESSORIES (December 11, 2013)

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