The following data is part of a premarket notification filed by Design Standards Corp. with the FDA for Flex Endoscopic Instruments.
| Device ID | K140662 |
| 510k Number | K140662 |
| Device Name: | FLEX ENDOSCOPIC INSTRUMENTS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | DESIGN STANDARDS CORP. 128 Blye HIll Landing Newbury, NH 03255 |
| Contact | Michele Lucey |
| Correspondent | Michele Lucey DESIGN STANDARDS CORP. 128 Blye HIll Landing Newbury, NH 03255 |
| Product Code | GCJ |
| Subsequent Product Code | GEI |
| Subsequent Product Code | GEX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-14 |
| Decision Date | 2014-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07208501900048 | K140662 | 000 |
| 00850190004735 | K140662 | 000 |
| 08008501900043 | K140662 | 000 |
| 00850190004810 | K140662 | 000 |
| 00850190004728 | K140662 | 000 |
| 00850190004681 | K140662 | 000 |
| 00850190004674 | K140662 | 000 |
| 00850190004650 | K140662 | 000 |
| 00850190004643 | K140662 | 000 |
| 00850190004636 | K140662 | 000 |
| 00850190004506 | K140662 | 000 |
| 00850190004490 | K140662 | 000 |
| 00850190004483 | K140662 | 000 |
| 00850190004476 | K140662 | 000 |
| 00850190004209 | K140662 | 000 |
| 02108501900046 | K140662 | 000 |
| 08108501900040 | K140662 | 000 |
| 06808501900041 | K140662 | 000 |
| 06708501900044 | K140662 | 000 |
| 00850190004667 | K140662 | 000 |
| 06508501900040 | K140662 | 000 |
| 06408501900043 | K140662 | 000 |
| 06308501900046 | K140662 | 000 |
| 05008501900046 | K140662 | 000 |
| 04908501900040 | K140662 | 000 |
| 04808501900043 | K140662 | 000 |
| 04708501900046 | K140662 | 000 |
| 02008501900049 | K140662 | 000 |
| 01608501900042 | K140662 | 000 |
| 07308501900045 | K140662 | 000 |
| 06608501900047 | K140662 | 000 |
| 00850190004162 | K140662 | 000 |