Company ยท US
Sage Products, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 1998. Name variants (Inc, Corp, punctuation) are merged.
31510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MMK | Container, Sharps | 5 |
| FMH | Container, Specimen, Sterile | 4 |
| FMI | Needle, Hypodermic, Single Lumen | 4 |
| LIO | Device, Specimen Collection | 3 |
| KDT | Container, Specimen Mailer And Storage, Sterile | 2 |
| BTX | Board, Arm (With Cover), Sterile | 1 |
| EIA | Unit, Operative Dental | 1 |
| FMT | Warmer, Infant Radiant | 1 |
| FXX | Mask, Surgical | 1 |
| FYC | Gown, Isolation, Surgical | 1 |
| KDQ | Bottle, Collection, Vacuum | 1 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 |
| KQT | Evacuator, Gastro-Urology | 1 |
| LKS | Device, Parasite Concentration | 1 |
| LWH | Counter, Sponge, Surgical | 1 |
| LYU | Accessory, Surgical Apparel | 1 |
| LZC | Medical Glove, Specialty | 1 |
| NSB | Patient Personal Hygiene Kit | 1 |
| NZU | Collector, Urine, Powered, Non Indwelling Catheter | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 30, 1998 | K972705 | RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC Sage Products, Inc. | FMI |
| Feb 24, 1998 | K980490 | SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS Sage Products, Inc. | MMK |
| Oct 29, 1997 | K973911 | 2 GALLON ALTERNATE CARE SHARPS CONTAINER Sage Products, Inc. | FMI |
| Aug 29, 1997 | K972279 | SHARPS SHUTTLE Sage Products, Inc. | FMI |
| Aug 25, 1997 | K970135 | NITRILE GLOVES Sage Products, Inc. | LZC |
| Jul 25, 1997 | K972302 | POCKET COUNT OR SAFETCOUNT Sage Products, Inc. | LWH |
| Mar 3, 1997 | K964168 | PROCEDURE SPECIFIC KITS Sage Products, Inc. | FXX |
| Nov 8, 1996 | K963986 | STP SYSTEM PVA WITH ZINC Sage Products, Inc. | LIO |
| Nov 7, 1996 | K964026 | STP SYSTEM - SAF Sage Products, Inc. | LIO |
| Nov 1, 1996 | K964027 | STP SYSTEM-PVA WITH MERCURY Sage Products, Inc. | LIO |
| Jul 22, 1996 | K962168 | MUCUS SPECIMEN TRAP Sage Products, Inc. | KDQ |
| Mar 22, 1995 | K943660 | PHLEBOTOMY SHARPS DISPOSAL CONTAINERS Sage Products, Inc. | MMK |
| Mar 22, 1995 | K943659 | ANCILLARY AND LARGE VOLUME SHARPS DISPOSAL CONTAINERS Sage Products, Inc. | MMK |
| Mar 22, 1995 | K943658 | CHEMOTHERAPY WASTE DISPOSAL CONTAINERS Sage Products, Inc. | MMK |
| Aug 29, 1994 | K941991 | IN-ROOM AND SHARPSTAR Sage Products, Inc. | MMK |
| Feb 17, 1994 | K933370 | STOOL TRANSPORT/PROCESSOR Sage Products, Inc. | LKS |
| Aug 15, 1990 | K901806 | SUCTION ORA-SWAB(R) BRUSH KIT Sage Products, Inc. | EIA |
| Aug 11, 1989 | K894064 | STERILE HAND COVER Sage Products, Inc. | LYU |
| Dec 30, 1987 | K874888 | ISOLATION GOWN Sage Products, Inc. | FYC |
| Nov 3, 1987 | K873569 | BLOOD NEEDLE HOLDER Sage Products, Inc. | FMI |
| Mar 29, 1983 | K823413 | MOUTH CARE KIT W/TOOTHBRUSH Sage Products, Inc. | |
| Dec 28, 1982 | K823411 | PEDIATRIC URINE COLLECTOR Sage Products, Inc. | KNX |
| Dec 15, 1982 | K823412 | ARM BOARD W/I.V COVERING Sage Products, Inc. | BTX |
| Feb 18, 1982 | K820246 | PREFILLED SPECIMEN CONTAINER Sage Products, Inc. | KDT |
| Jan 25, 1982 | K813408 | SAGE 2200 STERILE SPECIMEN CONTAINER Sage Products, Inc. | FMT |
| Jun 20, 1980 | K800946 | URINARY CATHETER SAMPLING KIT Sage Products, Inc. | KDT |
| May 30, 1980 | K800947 | MIDSTREAM COLLECTION KIT Sage Products, Inc. | FMH |
| Mar 10, 1980 | K800397 | ELLIK BLADDER EVACUATOR Sage Products, Inc. | KQT |
| Feb 26, 1980 | K800309 | SPECIMEN COLLECTION PAN Sage Products, Inc. | FMH |
| Apr 10, 1979 | K790291 | OPERATING ROOM SPECIMEN CONTAINER Sage Products, Inc. | FMH |
| Oct 17, 1978 | K781557 | 24-HOUR URINE COLLECTION COOLING WRAP Sage Products, Inc. | FMH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2023 | Sage Products Inc stryker Sage PrimaFit External Urine Management System for the Female Anatomy Open, Classified |
NZU | None listed |
| Dec 5, 2018 | Sage Products Inc Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in Independent Care System. The system is an oral care convenience kit which includes: an Ultra-Soft Toothbrush, 0.5 oz. Terminated |
NSB | None listed |