The following data is part of a premarket notification filed by Katalyst Surgical, Llc with the FDA for Kogent Spetzler Lighted Suction Tubes.
| Device ID | K141781 |
| 510k Number | K141781 |
| Device Name: | KOGENT SPETZLER LIGHTED SUCTION TUBES |
| Classification | Illuminator, Fiberoptic, Surgical Field |
| Applicant | KATALYST SURGICAL, LLC 754 Goddard Ave Chesterfield, MO 63005 |
| Contact | Meryl Koch |
| Correspondent | Meryl Koch KATALYST SURGICAL, LLC 754 Goddard Ave Chesterfield, MO 63005 |
| Product Code | HBI |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-02 |
| Decision Date | 2015-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817489025243 | K141781 | 000 |
| 10817489025212 | K141781 | 000 |
| 10817489025229 | K141781 | 000 |
| 10817489025236 | K141781 | 000 |
| 10817489025250 | K141781 | 000 |
| 10817489025267 | K141781 | 000 |
| 10817489025274 | K141781 | 000 |
| 10817489025281 | K141781 | 000 |
| 10856312006011 | K141781 | 000 |
| 10856312006028 | K141781 | 000 |
| 10856312006035 | K141781 | 000 |
| 10856312006042 | K141781 | 000 |
| 10856312006059 | K141781 | 000 |
| 10856312006066 | K141781 | 000 |
| 10856312006073 | K141781 | 000 |
| 10856312006080 | K141781 | 000 |
| 10856312006097 | K141781 | 000 |
| 10817489025205 | K141781 | 000 |