VTU-1 VACUUM ERECTION SYSTEM— 510(k) K971257

Substantially Equivalent

Mckenna & Cuneo

FDA 510(k) clearance K971257 for VTU-1 VACUUM ERECTION SYSTEM, Substantially Equivalent on 1997-10-03. Applicant: Mckenna & Cuneo. Device class: 2.

Clearance details

Applicant: Mckenna & Cuneo
Product code: Code LKY
Device class: Class 2
Regulation: 21 CFR 876.5020
Advisory panel: Gastroenterology, Urology
Date received: 1997-04-04
Decision date: 1997-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LKY

K041573 — NANMA VACUUM PUMP PROXZEK MODEL 2M9498S2004-08-25
K032776 — VACURECT VACUUM CONSTRICTION DEVICE2003-10-03
K030119 — NANMA ADJUSTABLE CONSTRICTION RING2003-08-06
K030913 — NANMA VACUUM PUMP2003-06-03
K013113 — MODIFICATION TO NANMA VACUUM PUMP2002-12-20

More clearances from Mckenna & Cuneo

K936312 — MANUAL MASSAGE ROLLER1996-01-29
K944547 — DANTEC KEYPOINT1995-09-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.