Surgitek NPT Monitor
FDA 510(k) K875333 · Surgitek
510(k) numberK875333
Submission
- Device name
- Surgitek NPT Monitor
- Applicant
- Surgitek
Racine, WI, US - Received
- December 30, 1987
- Decision date
- April 13, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIL – Monitor, Penile Tumescence
- Device class
- Unclassified
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| K980627 | Neva SystemLIL · Traditional | Urometrics, Inc. | 04/07/1998SE |
| K940128 | CAT-400UL Penile PlethysmographLIL · Traditional | Farrall Instruments, Inc. | 01/10/1995SE |
| K936115 | CAT-600 Penile PlethysmographLIL · Traditional | Farrall Instruments, Inc. | 01/10/1995SE |
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| K930483 | Ureteral CatheterEYB · Traditional | 07/16/1993SESK |
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Questions and answers
When was Surgitek NPT Monitor cleared by the FDA?
Surgitek NPT Monitor (K875333) received a 510(k) decision of Substantially Equivalent on April 13, 1988, 105 days after the submission was received.
What is the product code of K875333?
The FDA product code is LIL – Monitor, Penile Tumescence, a Unclassified device.