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510(k) K861372

ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORY by Snowden-Pencer — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1986
Date Received
April 11, 1986
Clearance Type
Traditional
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 Snowden-Pencer

  • K960400 — DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMO (March 12, 1996)
  • K930666 — REUSABLE LAPAROSCOPIC INSTRUMENTS W/ ELECTROCAUTERY (May 19, 1994)
  • K930667 — REUSABLE LAPAROSCOPIC INSTRUMENTS (May 16, 1994)
  • K924148 — DIAMOND-SHARP(R) TROCARS (February 28, 1994)
  • K924149 — ENDO I/A PROBE (January 26, 1993)
  • K920985 — SNOWDEN-PENCER IRRIGATION PUMP (June 9, 1992)
  • K920986 — SNOWDEN-PENCER HIGH FLOW INSUFFLATOR, SP/88-9700 (June 4, 1992)
  • K913979 — ENDO I/A Y SET (November 27, 1991)
  • K913835 — SNOWDEN-PENCER INSUFFLATOR TUBING SET (November 7, 1991)

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