Kundin Wound Gauge
FDA 510(k) K863409 · Jane I. Kundin
510(k) numberK863409
Submission
- Device name
- Kundin Wound Gauge
- Applicant
- Jane I. Kundin
San Mateo, CA, US - Received
- September 3, 1986
- Decision date
- September 29, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FTY – Tape, Measuring, Rulers And Calipers
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FTY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K160501 | Noxilizer Surgical RulerFTY · Traditional | Noxilizer, Inc. | 05/26/2016SE |
| K951064 | Disposable Wound Measure Guide, Plastic, Protector, Wound, PlasticFTY · Traditional | S-E Sales & Distribution, Inc. | 05/19/1995SE |
| K934930 | Olympic Auto-LengthFTY · Traditional | Olympic Medical Corp. | 12/29/1993SE |
| K932112 | Olympic Infa-LengthFTY · Traditional | Olympic Medical Corp. | 07/22/1993SE |
| K883485 | Stryker Pressure Monitor SystemFTY · Traditional | Stryker Corp. | 09/13/1988SE |
| K880441 | Pediatric Airway Measurement System & P.A.M.S.FTY · Traditional | Plane Iii, Inc. | 02/18/1988SE |
| K874352 | TumorimeterFTY · Traditional | Cancer Technologies, Inc. | 11/23/1987SE |
| K873470 | TemplateFTY · Traditional | Cox-Uphuff Intl. | 09/08/1987SE |
| K872319 | LN 100 Breast MarkerFTY · Traditional | Instrumentation Industries, Inc. | 08/11/1987SE |
| K862576 | PS2 Brand Facial Symmetry Guide (Lee Design)FTY · Traditional | Professional Services For Surgeons, Ltd. | 07/15/1986SE |
Questions and answers
When was Kundin Wound Gauge cleared by the FDA?
Kundin Wound Gauge (K863409) received a 510(k) decision of Substantially Equivalent on September 29, 1986, 26 days after the submission was received.
What is the product code of K863409?
The FDA product code is FTY – Tape, Measuring, Rulers And Calipers, a Class I (low risk) device regulated under 21 CFR 878.4800.