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510(k) K881413

ELECTRO-CAUTERY SUCTION TUBE by Alto Development Corp. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1988
Date Received
April 4, 1988
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 Alto Development Corp.

  • K964621 — A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTON (December 20, 1996)
  • K932513 — LABELING FOR MYO/WIRE II STERNOTOMY SUTURES (January 7, 1994)
  • K931537 — A&E MEDICAL ELECTROSURG ELECTRO W/NON-STICK COAT (September 7, 1993)
  • K930528 — A&E MEDICAL ELECTROSURGICAL CONNECTING CORDS (May 17, 1993)
  • K914193 — A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT (October 5, 1992)
  • K915300 — A & EM MEDICAL ELECTROSURGICAL PENCIL/ACCESSORIES (February 18, 1992)
  • K884783 — RANEY CLIP (November 30, 1988)
  • K831867 — PRESSURE MONITORING IV BOTTLE CAP (August 12, 1983)
  • K821518 — MYO/CLIP (July 8, 1982)

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