510(k) K151567
- Device
- ENDOPLUS Hand-held Laparoscopic Instruments
- Applicant
- ENDOPLUS
- 510(k) number
- K151567
- Product code
- HFI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-12-23
- Date received
- 2015-06-10
- Regulation
- 884.4160
- Classification name
- Coagulator, Culdoscopic (and Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Matthew Gudeman
- Address
- 750 Tower Rd., Suite A Mundelein IL US 60060 60060
FDA Registration Numbers#
- 9610773
- 1836161
- 3013247477
- 3002807310
- 9617070
- 1423714
- 1923569
- 3011050570
- 8030607
Source Documents#
Other 510(k) Records For Product Code HFI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K925957 | SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE | Zinnanti Surgical Instruments, Inc. | 1994-06-07 |
| K925960 | FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE | Zinnanti Surgical Instruments, Inc. | 1994-06-07 |
| K936026 | COOK LAPAROSCOPIC MINI RETRACTOR SET | Cook Urological, Inc. | 1994-03-11 |
| K924148 | DIAMOND-SHARP(R) TROCARS | Snowden-Pencer | 1994-02-28 |
| K925114 | LAPAROSCOPIC INSTRUMENTS | Endo Technic Corp. | 1994-02-28 |
| K930571 | REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING | Numed Technologies, Inc. | 1994-02-01 |
| K844053 | CANON 60 DEGREE FUNDUS CAMERA CF-60S | Canon USA, Inc. | 1984-12-19 |
Legacy Summary#
summary
FDA Review#
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