510(k) K072814
- Device
- CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES
- Applicant
- COVIDIEN
- 510(k) number
- K072814
- Product code
- KDD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-04-16
- Date received
- 2007-10-01
- Regulation
- 878.4800
- Classification name
- Kit, Surgical Instrument, Disposable
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT ZOTT
- Address
- 60 Middletown Ave. North Haven CT US 06473 06473
FDA Registration Numbers#
- 1123137
- 3007123908
- 2245304
- 1060680
- 3009703496
- 3004892425
- 9611024
- 1000614268
- 3010041511
- 1226074
- 3007420745
- 3010131137
- 3018544165
- 3005083075
- 3015173212
- 3011525245
- 3004519921
- 3033589330
- 1313525
- 3016215282
- 2245270
- 3014457631
- 3006673317
- 3012568936
- 3005669815
- 3013756169
- 9615765
- 1035236
- 1820334
- 1219930
- 3015058854
- 3039406055
- 3006191977
- 3010659131
- 3015487912
- 1034876
- 1526611
- 3020468145
- 3004992978
- 9617977
- 2531684
- 3013530901
- 3009746061
- 1417592
- 9681465
- 3023191945
- 3011499367
- 3014644369
- 3015143057
- 3030067857
- 3006542380
- 3023265483
- 3016171914
- 3010155661
- 1721504
- 3014637079
- 3012478585
- 3010470577
- 3006950086
- 3004125670
- 3009495876
- 3013840437
- 3019798849
- 8010273
- 1211566
- 3013307971
- 9680002
- 3011680076
- 3012130008
- 3008902714
- 3010462278
- 3003139373
- 8044099
- 3018094310
- 1643817
- 3008812560
- 3007607706
- 1526534
- 3022862651
Source Documents#
Other 510(k) Records For Product Code KDD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K011514 | INSTRUMENTS FOR ONE TIME USE - DISPOSABLE | Kencap , Ltd. | 2001-08-13 |
| K971317 | NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS | National Healthcare Mfg. Corp. | 1997-05-08 |
| K960456 | DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY | Denver Biomaterials, Inc. | 1996-04-01 |
| K936255 | CUSTOM CV PACK | Associated Medical | 1994-03-31 |
| K932219 | SUTURE SET OR LACERATION TRAYS (PACKS) | Associated Medical Products Co. | 1993-07-09 |
| K923176 | SURGICAL INSTRUMENT KIT, DISPOSABLE | Ulti-Med Intl., Inc. | 1993-06-17 |
| K925905 | KIT, SURGICAL INSTRUMENT, DISPOSABLE | Kay Medical Concepts | 1993-06-16 |
| K924958 | BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY | Medical Insights, Inc. | 1993-06-07 |
| K925215 | STERILE SURGICAL INSTRUMENT TRAYS | American Healthcare Supply Co., Inc. | 1993-06-01 |
| K924117 | DEXIDE LAPAROSCOPIC KITS | Dexide, Inc. | 1993-03-23 |
| K920989 | SURGICAL INSTRUMENT KIT, DISPOSABLE | Ulti-Med Intl., Inc. | 1992-10-19 |
| K920763 | LACERATTION TRAY | Sterile Concepts, Inc. | 1992-09-28 |
| K920516 | GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB | Trinity Laboratories, Inc. | 1992-04-16 |
| K914244 | STERILE CUSTOM SURGICAL KITS | Ulti-Med Intl., Inc. | 1992-02-24 |
| K913049 | SLIP-PRUF-CLINGER | Macbrud Corp. Medical Div. | 1991-09-11 |
Legacy Summary#
summary
FDA Review#
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