The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Endopath Bladeless Trocar, Endopath Blunt Tip Trocar, Endopath Dilating Tip Trocar.
Device ID | K032676 |
510k Number | K032676 |
Device Name: | ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH DILATING TIP TROCAR |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
Contact | Elizabeth Miller |
Correspondent | Elizabeth Miller ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-08-29 |
Decision Date | 2003-10-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30705036013765 | K032676 | 000 |
30705036001335 | K032676 | 000 |
30705036001328 | K032676 | 000 |
30705036001250 | K032676 | 000 |
30705036001243 | K032676 | 000 |
30705036001236 | K032676 | 000 |
40705036001226 | K032676 | 000 |
30705036001205 | K032676 | 000 |
30705036001199 | K032676 | 000 |
30705036001182 | K032676 | 000 |
30705036001175 | K032676 | 000 |
30705036001168 | K032676 | 000 |
30705036001151 | K032676 | 000 |
30705036001144 | K032676 | 000 |
30705036001137 | K032676 | 000 |
30705036001120 | K032676 | 000 |
30705036001113 | K032676 | 000 |
40705036001349 | K032676 | 000 |
30705036001359 | K032676 | 000 |
30705036013758 | K032676 | 000 |
30705036013741 | K032676 | 000 |
30705036013734 | K032676 | 000 |
30705036013727 | K032676 | 000 |
30705036013710 | K032676 | 000 |
30705036013703 | K032676 | 000 |
30705036002301 | K032676 | 000 |
30705036002295 | K032676 | 000 |
30705036002288 | K032676 | 000 |
30705036002271 | K032676 | 000 |
30705036002011 | K032676 | 000 |
30705036001601 | K032676 | 000 |
30705036001595 | K032676 | 000 |
30705036001588 | K032676 | 000 |
30705036001571 | K032676 | 000 |
30705036001564 | K032676 | 000 |
30705036001106 | K032676 | 000 |