NiC 1800 Needle Disposal System
by Nic, Ltd.
PMA P970036
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP970036 | Date26 Sep 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Sharps needle destruction device
- FDA applicant
- Nic , Ltd.
- PMA Number
- FDA Product Code
- MTV
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6210
- Advisory Committee
- General Hospital
- FDA Decision
- APRL
Overview
AI-generated summary, 18 Sep 2026
The NiC 1800 Needle Disposal System is a sharps needle destruction device designed for the safe disposal of standard plastic syringe-mounted hypodermic needles. It accommodates needles ranging from 19 gauge to 28 gauge and up to 2 inches in length, ensuring secure containment to prevent accidental sticks or injuries during clinical use.
This single-use device is intended for use in patient treatment and clinical laboratory settings, where it provides a controlled method for disposing of used needles. Supplied sterile and packaged individually, it adheres to regulatory standards as outlined in FDA PMA approval (P970036). The system is classified under device class II and falls under regulation number 880.6210 for sharps needle destruction devices.
Questions
AI-generated answers, 18 Sep 2026
What types of needles can the NiC 1800 Needle Disposal System safely handle, and why is this important for clinical settings?
The NiC 1800 Needle Disposal System is designed to safely contain needles ranging from 19 gauge to 28 gauge and up to 2 inches in length. This wide range ensures compatibility with most standard plastic syringe-mounted hypodermic needles used in patient treatment and clinical laboratory settings, reducing the risk of accidental sticks or injuries during disposal. The secure containment mechanism is critical for protecting healthcare workers and patients from needle-related injuries, which can transmit infections or cause trauma.
Is the NiC 1800 Needle Disposal System intended for reuse, and if not, how is it supplied to ensure safety and sterility?
No, the NiC 1800 Needle Disposal System is explicitly designed for single-use only. It is supplied sterile and packaged individually, which ensures that each unit is uncontaminated before use. This packaging maintains sterility and prevents cross-contamination between uses, aligning with best practices for sharps disposal in clinical environments.
How does the NiC 1800 Needle Disposal System differ from other sharps disposal devices in terms of its regulatory approval process?
The NiC 1800 Needle Disposal System holds an FDA Premarket Approval (PMA) under PMA number P970036, which is a rigorous review process for higher-risk medical devices. This approval confirms that the device meets strict safety and effectiveness standards for destroying needles (19–28 gauge, up to 2 inches) in patient treatment and clinical laboratory settings. Unlike Class I or some Class II devices that may require less extensive review, a PMA ensures the device’s design and performance have been thoroughly validated for its intended use.
What clinical environments is the NiC 1800 Needle Disposal System approved for, and why is this specification relevant?
The NiC 1800 Needle Disposal System is approved for use in patient treatment and clinical laboratory settings, as outlined in its FDA PMA approval. This specification is relevant because it clarifies the device’s intended operational context—where needles are frequently used and disposed of—ensuring healthcare providers in these environments can rely on it for safe, compliant sharps disposal. The approval does not extend to non-clinical areas like home use or non-medical settings.